Browse Device Recalls
1,125 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,125 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 1,125 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 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 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. |
| 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. |
| 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. |
| 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.