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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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.

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DateProductReasonClassFirm
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 7... 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 CONCENTRIC DOME PATELLA-SZ #7 -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 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -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 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 LEFT SMALL-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 TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -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 PS LIPPED TIBIAL INSERT ASSY 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 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Prod... 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.
May 3, 2023 Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is... Class II Howmedica Osteonics Corp.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende... Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produ... Class II Howmedica Osteonics Corp.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intende... Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produc... Class II Howmedica Osteonics Corp.
Nov 7, 2022 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Oct 21, 2022 Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog N... Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had o... Class II Howmedica Osteonics Corp.
Aug 24, 2022 Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis co... A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ... Class II Howmedica Osteonics Corp.
Mar 30, 2022 Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Tri... Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial C... Class II Howmedica Osteonics Corp.
Jan 14, 2022 Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... Class II Howmedica Osteonics Corp.
Jan 14, 2022 Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... Class II Howmedica Osteonics Corp.
Dec 30, 2021 Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... Class II Howmedica Osteonics Corp.
Dec 30, 2021 Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... Class II Howmedica Osteonics Corp.
Dec 21, 2021 Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Dec 21, 2021 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Nov 24, 2021 Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage... Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel ... Class II Howmedica Osteonics Corp.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 XXX Class II Howmedica Osteonics Corp.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 There is a potential for the outer white Tyvek lid to debond from the sealed package. Class II Howmedica Osteonics Corp.
Jul 1, 2021 Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a w... Class II Howmedica Osteonics Corp.
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Feb 10, 2021 Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,... Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Bas... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 1, 2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Shipments were transported outside of the required refrigerated temperature conditions. Potential... Class II Howmedica Osteonics Corp.
Nov 7, 2019 Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless... May have a missing locking wire causing delay in surgery while retrieving a back-up device or imp... Class II Howmedica Osteonics Corp.
Oct 3, 2019 Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to... Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wa... 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.