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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

124 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 124 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 124 FDA device recalls.

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DateProductReasonClassFirm
Sep 23, 2026 HexaVue Focus Integration System, a single, all-in-one system that handles op... A software issue may result in unintended mismatch of patient information on manually printed ima... Class II Steris Corporation
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... Class II Steris Corporation
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... Class II Steris Corporation
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... Class II Steris Corporation
Aug 31, 2026 VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
Aug 31, 2026 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
Aug 31, 2026 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Numb... Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
Aug 31, 2026 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number... Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
Aug 31, 2026 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
Aug 31, 2026 VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... Class II Steris Corporation
May 15, 2026 ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
Nov 19, 2025 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De... Wire connected to the electrical box may shift out of its intended position, which may result in ... Class II Steris Corporation
Nov 19, 2025 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des... Wire connected to the electrical box may shift out of its intended position, which may result in ... Class II Steris Corporation
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
May 23, 2025 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6... This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jan 9, 2024 Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Dec 12, 2023 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Dec 12, 2023 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Nov 16, 2023 V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc... Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Th... Class II Steris Corporation
Nov 13, 2023 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... Identification label on affected hookups could become illegible over time due to the label's ink ... Class II Steris Corporation
Apr 10, 2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present in the drying chambe... Class II Steris Corporation
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Oct 17, 2022 GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ... Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri... Class II Steris Corporation
Sep 2, 2022 Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 The scalpel holder may separate from the handle for certain lots. If the tip falls off during use... Class II Steris Corporation
Aug 10, 2022 Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... Product contains incorrect chemical indicators in packaging. Class III Steris Corporation Hopkins Facility
Apr 22, 2022 Reliance Synergy Washer/Disinfector The firm identified that when the electrical contactor component in the drying chamber of the Was... Class II Steris Corporation
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2... Product not approved for release for US distribution Class II Steris Corporation
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2... Product not approved for release for US distribution Class II Steris Corporation
Jan 21, 2021 OT1000 Series Orthopedic Surgical Tables On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assem... Class II Steris Corporation
Dec 11, 2020 Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f... The electrical contactor component present in the drying chamber of the Reliance Vision Single-Ch... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam ... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation

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.