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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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Dec 22, 2021 JAGTOME RX 49-30-260-035 Material Number: M00573020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-30-450-035 Material Number: M00573030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material N... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/450CM Material Number: M00584020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-260-025 Material Number: M00573080 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-450-035 Material Number: M00573050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-450-035 Material Number: M00573070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-450-025 Material Number: M00573110 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-260-035 Material Number: M00573060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Num... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/260CM Material Number: M00584010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 ... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/450CM Material Number: M00584070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-20-260-035 Material Number: M00573000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/450CM Material Number: M00584030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/260CM Material Number: M00584000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-450-025 Material Number: M00573090 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/260CM Material Number: M00584050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-260-035 Material Number: M00573040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 17, 2021 Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon C... The firm has received six (6) complaint reports from customers indicating difficulty removing the... Class II Covidien Llc
Dec 14, 2021 OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ... The firm has received complaints of the OXY-1 System Console experiencing a power interruption wh... Class I Abiomed, Inc.
Dec 7, 2021 Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- ... Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the N... Class II Fresenius Medical Care Holdings, Inc.
Dec 6, 2021 LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number L... Customers reported that the device jaws were difficult to open or would not open following applic... Class II Covidien Llc
Nov 30, 2021 Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental impl... Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... Class II Straumann USA LLC
Nov 30, 2021 Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... Class II Straumann USA LLC
Nov 29, 2021 Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... Class II Philips North America Llc
Nov 29, 2021 Infant Heel Warmers w/strap, Reference # 989805603201 1223 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... Class II Philips North America Llc
Nov 29, 2021 Heel Snuggler, Reference # 989805603411 99047 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... Class II Philips North America Llc
Nov 29, 2021 Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... Class II Philips North America Llc
Nov 26, 2021 Infa-Therm Transport Mattress, Reference Number 989805616831 1015 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... Class II Philips North America Llc
Nov 24, 2021 Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a ... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips North America Llc
Nov 24, 2021 Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluorosco... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips North America Llc
Nov 19, 2021 Philips Allura Xper FD series with Software Version Number: 2.1.x- intended f... Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mount... Class II Philips North America Llc
Nov 17, 2021 Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.

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.