Browse Device Recalls
335 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 335 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 335 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2026 | TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthop... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSER... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 ... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 1... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENO... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 8... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant compon... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Ortho... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F A... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| May 19, 2026 | TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| May 19, 2026 | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| Feb 2, 2026 | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | A potential issue was identified with the torque strength on the external screws of the MICS3 Ang... | Class II | Howmedica Osteonics Corp. |
| Nov 12, 2025 | The Stryker CranialMask Tracker is a single-use device consisting of a flexib... | When the device is activated during surgery, the device software issues an error message "Instrum... | Class II | Howmedica Osteonics Corp. |
| Aug 28, 2025 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... | Class II | Howmedica Osteonics Corp. |
| Sep 4, 2024 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may pre... | Class II | Howmedica Osteonics Corp. |
| Aug 7, 2024 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant valu... | Class II | Howmedica Osteonics Corp. |
| Aug 5, 2024 | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs ... | A patient specific, custom-made device was supplied for a surgical procedure that did not match t... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| May 23, 2024 | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... | Class II | Howmedica Osteonics Corp. |
| May 23, 2024 | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 621... | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 7 9 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 3 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | 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.