Browse Device Recalls
3,192 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,192 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 3,192 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 15, 2012 | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 13, 2012 | seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product ... | Sterility of product may be compromised due to packaging defect | Class II | Genzyme Corporation |
| Jun 13, 2012 | seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Pro... | Sterility of product may be compromised due to packaging defect | Class II | Genzyme Corporation |
| Jun 11, 2012 | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... | This letter is to notify you that several of our sterile screw products are being voluntarily rec... | Class II | Tedan Surgical Innovations Llc |
| Jun 1, 2012 | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipo... | Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in tha... | Class II | PSC Industries Inc |
| May 16, 2012 | LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within i... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within ... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within ... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within ... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within ... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 10 Packaging: The product was packaged within inner and oute... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within i... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within i... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within i... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within ... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer b... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| May 16, 2012 | LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... | Class II | DePuy Orthopaedics, Inc. |
| Jan 26, 2012 | Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... | Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 1, 2009 | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jan 9, 2007 | No packaging. The device is a computed tomography scanner. Intended to ... | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in te... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 27, 2005 | Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... | The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... | Class II | Philips Medical Systems (Cleveland) 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.