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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

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
Jul 16, 2018 AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 13, 2018 Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OP... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... Class II Haemonetics Corporation
Jul 13, 2018 Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 20... In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jul 13, 2018 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2... In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jul 13, 2018 Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 Ortho... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... Class II Haemonetics Corporation
Jul 13, 2018 Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 11, 2018 TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jun 29, 2018 MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Us... QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QF... Class II Mevion Medical Systems, Inc.
Jun 20, 2018 Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14... Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablati... Class II Boston Scientific Corporation
Jun 19, 2018 AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penet... The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU... Class II LeMaitre Vascular, Inc.
Jun 18, 2018 Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmi... Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the ... Class II Beaver Visitec
Jun 11, 2018 NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) ... There is a potential risk of electrical fire when fluid leaks into the power receptacle on the ba... Class II NxStage Medical, Inc.
Jun 11, 2018 Allura Xper Product Usage: Vascular,cardiovascular and neurovascular im... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
Jun 11, 2018 UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging a... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
Jun 11, 2018 Centron Product Usage: Vascular,cardiovascular and neurovascular imagin... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
May 18, 2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... The Internal packaging, the pouch and patient labels are improperly labeled. Class II OMNIlife science Inc.
May 14, 2018 Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to m... Blades are loose in handles and may fall out due to non cured epoxy Class II Beaver Visitec
May 10, 2018 Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage... Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in th... Class II Anika Therapeutics, Inc.
May 8, 2018 Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: ... Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. Class III Human Design Medical Llc
May 7, 2018 cobas m 511 integrated hematology analyzer, Model Number 07261691190 Produ... Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficie... Class II Roche Diagnostics Hematology
May 3, 2018 HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (8612... The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may... Class II Philips Electronics North America Corporation
May 2, 2018 NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... The bottles are mislabeled with an incorrect part number. Class II Fresenius Medical Care Renal Therapies Group, LLC
May 1, 2018 Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... The implants are mislabeled. Class II Keystone Dental Inc
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 25, 2018 Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... Class II Conseal International, Inc.
Apr 17, 2018 Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C6... There is a potential for the cord to spark and cause a fire. Class II Gyrus Acmi, Incorporated
Apr 11, 2018 NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP... Distal tips of the probes may detach from the probe shaft during use. Class II Ninepoint Medical Inc.
Mar 28, 2018 Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to ach... The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead ... Class II Ace Surgical Supply Co., Inc.
Mar 28, 2018 Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... Software anomaly resulting in the loss of patient settings and stored patient data. Class II Draegar Medical Systems, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number ... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article N... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Numbe... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article N... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Numbe... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 16, 2018 ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic devi... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/P... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America 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.