Medical device recalls
2545 recalls.
- Carevo recall (ARJOHUNTLEIGH POLSKA Sp. z.o.o.)
Medical deviceClass IIReported November 4, 2026 · The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling.... - Precision Pointer Electromagnetic recall (Stryker Leibinger GmbH & Co. KG)
Medical deviceClass IIReported November 4, 2026 · Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is... - Nalu TD2 Therapy Disc with firmware recall (Boston Scientific Neuromodulation Corporation)
Medical deviceClass IIReported November 4, 2026 · Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue... - PENTAX Medical Water bottle assembly. Model Number. OS-H5. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - CareLink SmartSync Device Manager App recall (Medtronic, Inc.)
Medical deviceClass IIReported November 4, 2026 · Software problem has the potential for an inaccurate displayed longevity estimate. - CareLink SmartSync recall (Medtronic, Inc.)
Medical deviceClass IIReported November 4, 2026 · Software problem has the potential for an inaccurate displayed longevity estimate. - CareLink SmartSync Programmer recall (Medtronic, Inc.)
Medical deviceClass IIReported November 4, 2026 · Software problem has the potential for an inaccurate displayed longevity estimate. - EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid... recall (BioMerieux SA)
Medical deviceClass IIReported November 4, 2026 · Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater... - Philips Azurion S. Model Number: 722285. recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 M20. Model Numbers: 722079 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 M12. Model Numbers: 722078 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 B20. Model Numbers: 722068 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 B12. Model Numbers: 722067 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 5 M20. Model Numbers: 722228 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 5 M12. Model Number: 722227. recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 3 M15. Model Number: 722064 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 3 M12. Model Numbers: 722063 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - Model Number: 712010. recall (Philips North America)
Medical deviceClass IIReported November 4, 2026 · Potential for the device to fail immediately after an exposure, causing the system to remain stationary. - Orthoscan VERSA Accessory Cart recall (ZIEHM-ORTHOSCAN INC)
Medical deviceClass IIReported November 4, 2026 · The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the... - OmniaSecure Model 3930M recall (Medtronic, Inc.)
Medical deviceClass IIReported November 4, 2026 · Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of... - ETHILON Nylon Suture recall (Ethicon, LLC)
Medical deviceClass IIReported November 4, 2026 · Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or... - Impella Connect Optical AIC recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Impella Optical Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30. recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 28, 2026 · A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. - Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31. recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 28, 2026 · A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. - MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SECTION FEN CLR SCREEN W recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - Xact mole marker for mammography Model/Catalog Number: M15RM recall (Solstice Corporation)
Medical deviceClass IIReported October 28, 2026 · The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. - InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT... recall (Medtronic Neuromodulation)
Medical deviceClass IIReported October 28, 2026 · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may... - InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI... recall (Medtronic Neuromodulation)
Medical deviceClass IIReported October 28, 2026 · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may... - Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported October 28, 2026 · A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier... - Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number:... recall (restor3d Inc.)
Medical deviceClass IIReported October 28, 2026 · Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Ion Torrent Genexus Dx with software recall (Life Technologies Holdings Pte Ltd)
Medical deviceClass IIReported October 28, 2026 · DNA or RNA sequencing system software has vulnerabilities. - Techno-Path Multichem AE Unassayed Level 3 recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Techno-Path Multichem AE Unassayed Level 2 REF: AE622X recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Techno-Path Multichem AE Unassayed Level 1 REF:AE621X recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Generic Name: Softmed Breathables Advanced Toric recall (CooperVision, Inc.)
Medical deviceClass IIReported October 28, 2026 · The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product... - CareLink Clinic recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported October 28, 2026 · CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values... - ROTOR ASSY-SW41 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break... - ROTOR ASSY-SW40 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a...