Sterility problems recalls (page 6)
732 recalls.
- See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DYNDA3003 recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC LINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SCC RF PAIN MGMT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANCILLARY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining... - ERBEFLO 2 recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - Medical Action Industries Inc. Pack Cath BHH recall (Medical Action Industries, Inc. 306)
Medical deviceClass IReported May 13, 2026 · Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the... - Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Similasan recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - iVIZIA recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - Optase Dry Eye Intense Drops recall (SCOPE HEALTH)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility - GenTeal Tears recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Systane recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline or Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098B Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and... recall (Zimmer, Inc.)
Medical deviceClass IIReported May 6, 2026 · Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or... - Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery... recall (Clinical Innovations, LLC)
Medical deviceClass IIReported May 6, 2026 · Due to complaints of device breakage at the traction force gauge to handle joint. - VACUUM BAG SU LARGE recall (Milestone S.R.L.)
Medical deviceClass IIReported May 6, 2026 · There is a possibility of reagent leakage from the specimen container. - LACTATED RINGER'S IRRIGATION recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - 0.9 % SODIUM CHLORIDE IRRIGATION recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - DEXTROSE INJECTION USP recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - Sterile Water for Injection USP recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - FRESHKOTE LUBRICANT EYEDROPS recall (Harrow Eye LLC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility - LSL Healthcare Wound Closure Tray recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - Flamingo Funnel Large recall (SurgiSmoke Solutions)
Medical deviceClass IIReported April 29, 2026 · Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. - Flamingo Funnel Medium recall (SurgiSmoke Solutions)
Medical deviceClass IIReported April 29, 2026 · Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. - Flamingo Funnel Small recall (SurgiSmoke Solutions)
Medical deviceClass IIReported April 29, 2026 · Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. - Lidocaine HCl Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Lidocaine HCl injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - EPINEPHRINE Injection recall (International Medication Systems Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Albuterol Sulfate Inhalation Solution recall (Nephron SC, LLC)
DrugClass IIReported April 22, 2026 · Labelling: Illegible label - Semaglutide-Glycine-Cyanocobalamin Injectable recall (PAYLESS COMPOUNDERS, LLC)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - CENTURION Circumcision Kit recall (Medline Industries, LP)
Medical deviceClass IIReported April 22, 2026 · On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. - Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported April 22, 2026 · Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. - Artificial Tears Lubricant Eye Drops recall (Preferred Pharmaceuticals, Inc.)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - Vancomycin HCL recall (Fagron Compounding Services)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Vancomycin HCI recall (Fagron Compounding Services)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Vancomycin HCI recall (Fagron Compounding Services)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - norepinephrine Bitartrate recall (Fagron Compounding Services)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - norepinephrine Bitartrate recall (Fagron Compounding Services)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - 0.45% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility - Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Artificial Tears Sterile Lubricant Eye Drops recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - STERILE EYE DROPS SOOTHING TEARS recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Sterile EYE DROPS REDNESS LUBRICANT recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Sterile Eye Drops ORIGINAL FORMULA recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Ultra Lubricating Eye Drops recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Dry Eye Relief Eye Drops recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - EYE DROPS Advanced Relief recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Sterile EYE DROPS AC recall (K.C. Pharmaceuticals, Inc)
DrugClass IIReported April 8, 2026 · Lack of Assurance of Sterility - Sterile Radiology Procedure Kits recall (Medline Industries, LP)
Medical deviceClass IIReported April 8, 2026 · There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. - Octreotide Acetate for Injectable Suspension recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported April 1, 2026 · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract... - Octreotide Acetate for Injectable Suspension recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported April 1, 2026 · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract...