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Browse Device Recalls

317 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 317 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 317 FDA device recalls.

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DateProductReasonClassFirm
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.
Dec 22, 2023 HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Pa... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS RT Intended for knee replacement Product ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... 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.