Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 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 437 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Sep 26, 2025	Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ...	Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit...	Class II	Zimmer, Inc.
Sep 26, 2025	Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ...	Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit...	Class II	Zimmer, Inc.
Mar 24, 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8...	The associated product labeling does not adequately provide compatibility information for use of ...	Class II	Zimmer, Inc.
Mar 24, 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8...	The associated product labeling does not adequately provide compatibility information for use of ...	Class II	Zimmer, Inc.
Mar 24, 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num...	The associated product labeling does not adequately provide compatibility information for use of ...	Class II	Zimmer, Inc.
Mar 24, 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num...	The associated product labeling does not adequately provide compatibility information for use of ...	Class II	Zimmer, Inc.
Mar 24, 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8...	The associated product labeling does not adequately provide compatibility information for use of ...	Class II	Zimmer, Inc.
Feb 27, 2025	NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co...	The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ...	Class II	Zimmer, Inc.
Feb 12, 2025	Z1 Femoral Hip System, Product Number 611777612	There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the d...	Class II	Zimmer, Inc.
Jan 6, 2025	NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ...	It was identified internally that two commingle events occurred where the metal support post with...	Class II	Zimmer, Inc.
Jan 6, 2025	NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ...	It was identified internally that two commingle events occurred where the metal support post with...	Class II	Zimmer, Inc.
Sep 17, 2024	Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in mi...	A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in ...	Class II	Zimmer, Inc.
Jul 2, 2024	CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip...	Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). T...	Class II	Zimmer, Inc.
Mar 28, 2024	NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of ...	Out of specification violation of devices that results in a gap existing within the fixture that ...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indic...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated f...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, 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.