Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 4, 2012 | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... | Damage to the packaging may have compromised the sterility of the device. | Class II | Ethicon Endo-Surgery Inc |
| Sep 13, 2012 | CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are... | Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... | Class II | Zimmer, Inc. |
| Sep 13, 2012 | CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are pri... | Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... | Class II | Zimmer, Inc. |
| Sep 13, 2012 | CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CP... | Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... | Class II | Zimmer, Inc. |
| Aug 22, 2012 | S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... | Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... | Class II | DePuy Orthopaedics, Inc. |
| Aug 21, 2012 | ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer... | SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... | Class I | Ethicon, Inc. |
| Aug 21, 2012 | ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed... | SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... | Class I | Ethicon, Inc. |
| Aug 17, 2012 | Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 ... | Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 17, 2012 | Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 ... | Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 10, 2012 | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 9, 2012 | Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... | Class II | Applied Medical Resources Corp |
| Aug 9, 2012 | Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... | Class II | Applied Medical Resources Corp |
| Aug 9, 2012 | Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... | Class II | Applied Medical Resources Corp |
| Jul 31, 2012 | DePuy Custom Implant Devices Packaging: Packaging was not standardized o... | In connection with a Warning Letter received from the U.S. Food & Drug Administration on December... | Class II | DePuy Orthopaedics, Inc. |
| Jul 24, 2012 | Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... | In the recalled lot, the products were not machined according to the production router, a size 52... | Class II | DePuy Orthopaedics, Inc. |
| Jul 20, 2012 | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... | Product is missing the label on the internal packaging. | Class III | Teleflex Medical |
| Jul 18, 2012 | Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers... | Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related... | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2012 | 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... | Class II | Nico Corp. |
| Jul 17, 2012 | 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... | Class II | Nico Corp. |
| Jul 13, 2012 | Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ... | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ... | Class II | Westone Laboratories, Inc. |
| Jun 15, 2012 | Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... | Class II | Exactech, Inc. |
| Jun 15, 2012 | Equinoxe Reverse Compression Screw 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 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. |
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.