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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

Consumer Safety

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
Dec 2, 2020 Vis-U-All High Temperature Tubing 6"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 6"x10" Heat Seal Pouch 200 pouches per box; 5 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 3.5"x9" 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 13"x18" Self Seal Pouch 100 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 Temperature Tubing 9"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 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Nov 19, 2020 Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrumen... STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseu... Class II Steris Corporation
Oct 7, 2020 Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ... Potential for cleaning solution intrusion into endoscope Class III Steris Corporation
Jun 26, 2020 InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ul... A recent FDA inspection at the firm identified that the foil test performed during installation o... Class II Steris Corporation
Oct 22, 2019 Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 ... Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (P... Class II Steris Corporation
Oct 22, 2019 Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain ... Class II Steris Corporation
Dec 26, 2018 ATLAS Loading Car The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when t... Class II Steris Corporation
Dec 20, 2018 AMSCO 3000 Series Washer/Disinfector Model # 3052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Dec 20, 2018 AMSCO 5000 Series Washer/Disinfector Model # 5052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Jul 26, 2018 AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Syst... There is the potential for a scenario where a punctured cup of sterilant expires while the system... Class II Steris Corporation
May 23, 2018 Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003... The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical ... Class II Steris Corporation
Sep 28, 2017 V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Oct 5, 2016 Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The... The Drager Pendula spring arm device has a set of screws located on the spring arm that were not... Class II Steris Corporation
May 23, 2016 OT1000 Series Orthopedic Surgical Tables STERIS has identified that the pivot pin assembly located on the table top may become loose preve... Class II Steris Corporation
Dec 4, 2015 Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC... The firm discovered that one of the hysteroscope models listed for processing in four existing Qu... Class II Steris Corporation
Nov 20, 2015 AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the ... The firm discovered that information printed on the quick reference magnet is incorrect; specific... 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.