Recalls in Pennsylvania (page 7)
4061 recalls.
- SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head recall (SEASPINE ORTHOPEDICS CORPORATION)
Medical deviceClass IIReported September 30, 2026 · The proximal thread depth of the spinal device is out of design specification. - CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors recall (Fresenius Medical Care Renal Therapies Group, LLC)
Medical deviceClass IIReported September 30, 2026 · Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. - PowerLED 300 Concealed Lighting System recall (Maquet SAS)
Medical deviceClass IIReported September 30, 2026 · The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. - REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post... recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - REF:HF2PC9 HomeFill Oxygen System recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module ... recall (Heidelberg Engineering GmbH)
Medical deviceClass IIReported September 30, 2026 · Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a... - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall (Boston Scientific Corporation)
Medical deviceClass IReported September 30, 2026 · Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged... - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. - ABC Trading Recalls Light-Up Children’s Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported September 24, 2026 · The recalled children’s toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries... - Love To Dream Recalls Portable Sleep Machines Due to Risk of Injury from Fire and Burn Hazards
Consumer productReported September 24, 2026 · The lithium-ion battery in the recalled portable sleep machines can overheat if the charger is not compatible with the unit, posing a risk of injury from fire... - INMO International Technology Limited Recalls INMO Air3 Smart Glasses Due to Risk of Serious Injury or Death from Burn Hazard
Consumer productReported September 24, 2026 · The left temple of the recalled smart glasses can overheat during extended use, posing a risk of serious injury or death due to burn hazard. - Style Homeware Recalls Emerspring Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Yuyitop Recalls Aitjunz 8-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported September 24, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Xinan Home Recalls WinxMatrs Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - NEWDERY Power Banks Recalled Due to Fire and Burn Hazards; Risk of Serious Injury; Sold on Amazon
Consumer productReported September 24, 2026 · The lithium-ion battery in the power banks can explode or ignite, posing fire and burn hazards to consumers. - The Blue Cactus Company Reclining Chair Battery Packs Recalled Due to Fire and Burn Hazards; Sold on Amazon
Consumer productReported September 24, 2026 · The lithium-ion battery in the recalled battery packs can overheat, posing fire and burn hazards to consumers. - Hyperfuels Recalls Methanol and Ethanol Fuel Containers Due to Risk of Serious Injury or Death from Child Poisoning and Flame Jetting; Violates Multiple Federal Safety Standards
Consumer productReported September 24, 2026 · The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under... - 5Color Recalls Children’s Bicycle Helmet and Pads Sets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
Consumer productReported September 24, 2026 · The helmets in the recalled sets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation... - ZCK01 Recalls Kesyup Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Hexing Haw Balls candy recall (Tiffany Food Corp)
FoodClass IIIReported September 23, 2026 · Unapproved dye Ponceau 4R - Buckhead recall (Buckhead Meat Company D.B.A. Trinity Seafood)
FoodClass IIReported September 23, 2026 · The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin. - Martina brand Fresh Whole Mangoes recall (Panorama Produce Sales Inc.)
FoodClass IIReported September 23, 2026 · Product may be contaminated with Salmonella - Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US recall (PI CARDIA LTD)
Medical deviceClass IIReported September 23, 2026 · Transfemoral catheter, positing arm may detached due to weld issue. - Boston Scientific Corporation StoneSmart Connect Console Contents: recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 23, 2026 · A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power... - REF:B5ST Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B5LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B12LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B11LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:2B5ST Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:2B5LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT... recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported September 23, 2026 · Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). - Happiest Baby recall (Happiest Baby, Inc)
Medical deviceClass IIReported September 23, 2026 · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. - Happiest Baby recall (Happiest Baby, Inc)
Medical deviceClass IIReported September 23, 2026 · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. - GM Helix Implant recall (Straumann USA LLC)
Medical deviceClass IIReported September 23, 2026 · There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Non-Dedicated Gravity Administration Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Plum administration sets recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Philips PIC iX Essentials REF:867093 recall (Philips North America)
Medical deviceClass IIReported September 23, 2026 · Due to software malfunction, patient information system may freeze and become unresponsive. - Philips Patient Information Center iX REF:866389 recall (Philips North America)
Medical deviceClass IIReported September 23, 2026 · Due to software malfunction, patient information system may freeze and become unresponsive. - BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump... recall (BD SWITZERLAND SARL)
Medical deviceClass IReported September 23, 2026 · Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. - DuoGlide Short-Term Straight Dialysis Catheter recall (Bard Access Systems, Inc.)
Medical deviceClass IReported September 23, 2026 · this is a downstream recall of class I recall RES 98777 - Power-Trialysis Short-Term Straight Dialysis Catheter recall (Bard Access Systems, Inc.)
Medical deviceClass IReported September 23, 2026 · this is a downstream recall of class I recall RES 98777 - Foods Alive organic moringa leaf powder recall (FOODS ALIVE INC.)
FoodClass IReported September 23, 2026 · Potential Salmonella contamination - Thyroid Tablets recall (VITRUVIAS THERAPEUTICS INC)
DrugClass IReported September 23, 2026 · Superpotent Drug - Dopamine HCl Inj. recall (Pfizer)
DrugClass IIReported September 23, 2026 · Lack of Assurance of Sterility - Chlorthalidone Tablets recall (Inventia Healthcare Limited)
DrugClass IIReported September 23, 2026 · Failed Dissolution Specifications - Lidocaine Ointment USP recall (SUN PHARMA /TARO)
DrugClass IIReported September 23, 2026 · Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - Fluphenazine HCl Elixir recall (Safecor Health, LLC)
DrugClass IIReported September 23, 2026 · Failed Stability Specifications - CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes:... recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under... - Reign Medical Clench Staple System recall (F & A Foundation)
Medical deviceClass IIReported September 23, 2026 · Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. - Convenience kits CATARACT PACK DYNJ59881A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 ... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 ... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 ... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported September 23, 2026 · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential... - Captus 4000e Thyroid Uptake System recall (Mirion Technologies (Capintec), Inc.)
Medical deviceClass IIReported September 23, 2026 · Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5... - Et Control recall (Datex-Ohmeda, Inc.)
Medical deviceClass IIReported September 23, 2026 · Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control... - Aisys CS2 with Et Control recall (Datex-Ohmeda, Inc.)
Medical deviceClass IIReported September 23, 2026 · Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control... - Aisys CS2 recall (Datex-Ohmeda, Inc.)
Medical deviceClass IIReported September 23, 2026 · Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control... - Aisys recall (Datex-Ohmeda, Inc.)
Medical deviceClass IIReported September 23, 2026 · Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control... - Blood Culture Collection Venipuncture Kit 20/Cs recall (Medical Action Industries, Inc. 306)
Medical deviceClass IIReported September 23, 2026 · Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may... - Kinos Axiom Total Ankle System with Axiom PSR recall (restor3d Inc.)
Medical deviceClass IIReported September 23, 2026 · Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard... - Brand Name: VERIQA recall (PTW FREIBURG)
Medical deviceClass IIReported September 23, 2026 · When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may... - SunMed Tracheal Tube recall (WELL LEAD MEDICAL CO. LTD)
Medical deviceClass IIReported September 23, 2026 · The 6Fr suction catheter could not pass through the samples smoothly. - Core Services Hub V8 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - Workflow Core Services V8 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - Centricity PACS Server V7 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - Centricity PACS V2 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - Enterprise Archive V8 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - Centricity Enterprise Archive V2 recall (GE Healthcare)
Medical deviceClass IIReported September 23, 2026 · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs... - NOxBOXi Nitric Oxide Delivery System. recall (NOXBOX LTD)
Medical deviceClass IIReported September 23, 2026 · Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. - Impella Optical Controller recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. - Impella Optical Controller with the below product descriptions and corresponding... recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.