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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Aug 8, 2018 ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 Bronchovidescope BF-1T240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-1T40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bronchovideoscope BF-1T180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-MP60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Ultrasonic Bronchoscope BF-UC180F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-P40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-P180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008... The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging ... Class II Philips North America LLC
Aug 8, 2018 Bronchovideoscope BF-MP160F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bronchovideoscope BF-3C40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-P60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Us... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-1T60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Airway Mobilescope MAF-TM The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.