Recalls affecting Pennsylvania
Notices that name Pennsylvania in their distribution area, plus every nationwide recall — nationwide recalls reach Pennsylvania too.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
DFI Co., Ltd. Uric Acid in vitro diagnostic test REF: 31H0P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Medline Convenience Kits: 1) Angio Procedure Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) KIT Surg ONC Excision Breast recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL recall: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
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Class II · 6 months ago
Medline Convenience Kits: 1) DYNDA3003 recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) SCC RF Pain Mgmt recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) Basic Nerve Block Tray W/Linen recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Physio-Control, Inc. Lifepak 15, REF: 99577-000025, 99577-000047 recall: Some defibrillators serviced between July 2023 through November 2025
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Open Heart CDS recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Centinel Spine, Inc. Prodisc C SK U.S. Implant Extra Large 5MM. Model: Pdsxl5 Total recall: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm…
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Class II · 6 months ago
Medline Convenience Kits: 1) Lithotomy Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step K in vitro diagnostic test REF: 81A4 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Medline Convenience Kits: 1) PPE KIT recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) WMC I D PACK-LF recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Plastic BIN recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 60 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class II · 6 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules USP, 60mg recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Class III · 6 months ago
Unichem Pharmaceuticals USA Inc. busPIRone Hydrochloride Tablets, USP recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 20 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…