Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 2, 2019 Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The I... Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. Class II Medela Inc
Nov 4, 2019 Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product... Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa... Class II Integra Lifesciences Sales Llc
Oct 24, 2019 Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT... Sterile packaging incomplete seals may compromise sterility of the product Class II Centurion Medical Products Corporation
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook 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.