Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 7, 2013 | 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 0059... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 0059720612... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femu... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 905... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-F... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 005970... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Ster... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 6, 2013 | AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal de... | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complet... | Class II | Sybron Dental Specialties |
| Jun 5, 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... | Class III | 3M Company - Health Care Business |
| May 31, 2013 | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... | Class II | Synthes (USA) Products LLC |
| May 30, 2013 | Exactech Articulated Driver A nonpowered hand-held device intended for me... | When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... | Class II | Exactech, Inc. |
| May 29, 2013 | Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI... | The information regarding the FILM Mode calibration may have been considered difficult to interpr... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2013 | Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM T... | A plate was inadvertently released to a sales consultant that was restricted for sale. | Class II | Synthes USA HQ, Inc. |
| May 24, 2013 | AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... | Class II | Fenwal Inc |
| May 23, 2013 | Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 ... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve with Catheter and Accessories ... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | Potential to electrostatic discharged (ESD) | Class II | HeartWare Inc |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device ... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Cathe... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Uniti... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Cat... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 16, 2013 | Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Cathet... | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | Class II | Codman & Shurtleff, Inc. |
| May 13, 2013 | ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack ... | Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (EC... | Class II | Ethicon Endo-Surgery Inc |
| May 3, 2013 | -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples ... | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... | Class II | Surgical Instrument Service And Savings, 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. |
| Apr 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... | Class II | Philips Medical Systems, Inc. |
| Apr 8, 2013 | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. | Class II | Philips Healthcare Inc. |
| Mar 28, 2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx... | On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were foun... | Class II | Custom Spine, Inc. |
| Mar 28, 2013 | Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfe... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Loc... | Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Dril... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 11, 2013 | Centricity Perinatal and Centricity Intensive Care is intended to be used in ... | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count ... | Class II | GE Healthcare It |
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.