Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
Jun 7, 2013 REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6A... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
May 15, 2013 Superior Approach Resection Guide Assembly. Indicated for primary, fractur... Biomet has initiated this action following an investigation which identified that the slot on the... Class II Biomet, Inc.
May 10, 2013 Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, LLC
May 10, 2013 Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (... A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, LLC
May 3, 2013 -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
Apr 29, 2013 Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Syst... Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which invo... Class II Biomet, Inc.
Apr 26, 2013 Active Articulation E1. Intended for use with either primary or revision h... Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this actio... Class II Biomet, Inc.
Mar 20, 2013 REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found i... Investigation of complaints found excessive use of the instrument could result in cracking on the... Class II Biomet U.K., Ltd.
Mar 14, 2013 The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For... Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect ... Class II Synvasive Technology Inc
Feb 10, 2013 ROSA Surgical Device 2.5.8 Issue with optional neuro-endoscopy module detected under specific conditions during internal tes... Class II Zimmer Biomet, Inc.
Feb 7, 2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-50017... Increased risk of failure at the driver tip during screw insertion or removal. Class II Ebi, Llc
Feb 5, 2013 REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Ortho... The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of... Class II Biomet, Inc.
Feb 5, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... Observed instability of the device. Class II Zimmer Biomet, Inc.
Jan 3, 2013 TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manu... Thru hole at the tip of the screw is undersized. Class II Biomet, Inc.
Nov 30, 2012 Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy... Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specific... Class II Biomet Spine, LLC
Nov 15, 2012 Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Produ... Biomet investigation identified that the square end of the offset tibial tray adaptor locking ins... Class II Biomet, Inc.
Nov 9, 2012 EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail S... It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel... Class II Biomet, Inc.
Nov 6, 2012 Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous ... It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it... Class II Biomet, Inc.
Nov 1, 2012 OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS ST... Biomet has initiated this action following an investigation which identified that the thin shaft ... Class II Biomet, Inc.
Nov 1, 2012 OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLES... Biomet has initiated this action following an investigation which identified that the thin shaft ... Class II Biomet, Inc.
Nov 1, 2012 Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Impla... The items in this lot are missing the ion implantation feature. The surface of the head may be so... Class II Biomet, Inc.
Oct 4, 2012 Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a met... The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) Class II Biomet, Inc.
Sep 29, 2012 Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Broken screw insertor hardness was measured and found to be below the acceptable limits. Class II Ebi, Llc
Sep 28, 2012 Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, a... Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... Class II Biomet 3i, LLC
Sep 28, 2012 Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA4... Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... Class II Biomet 3i, LLC
Aug 23, 2012 Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity... Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... Class II 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.