Browse Device Recalls

1,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,522 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 1,522 FDA device recalls.

Clear
DateProductReasonClassFirm
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.
Aug 23, 2012 Optilock 2.7 mm Screw Inserter. 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.
Aug 14, 2012 JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is i... Investigation found that the current design of the product allows the press-fit of the knob/shaft... Class II Biomet, Inc.
Aug 3, 2012 Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental I... Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percen... Class II Biomet 3i, LLC
Jul 27, 2012 Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate che... A drafting error during an unrelated design change has led to 4 misleading dimensions on the draw... Class II Biomet U.K., Ltd.
May 31, 2012 Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is l... Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due ... Class II Biomet 3i, LLC
Apr 19, 2012 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Potential failure of the optical distance sensor due to cable disconnection. Class II Zimmer Biomet, Inc.
Mar 23, 2012 ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile ... Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth o... Class II Biomet 3i, LLC
Feb 22, 2012 Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX,... Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due t... Class II Biomet Spine, LLC
Dec 19, 2011 Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is ... The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in pla... Class II Biomet Spine, LLC
Nov 4, 2011 Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection... On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certa... Class II Biomet 3i, LLC
May 6, 2011 Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the P... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneuma... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Product Catalog (part number 20-0020) utilized with the Electric and Pneumati... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
Mar 9, 2011 LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization ... Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw... Class II Biomet Spine LLC.
Dec 12, 2006 PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile... Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation whi... 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.