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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
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 13, 2017 NEODENT CM Intraoral Scanbody, Article Number: 108.139 During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139... Class II Instradent USA, Inc.
Mar 9, 2017 Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection ... Straight PrimaConnex Implants contained Tapered PrimaConnex Implants Class II Keystone Dental Inc
Mar 8, 2017 Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 te... Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... Class II Siemens Healthcare Diagnostics, Inc
Mar 8, 2017 Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tes... Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... Class II Siemens Healthcare Diagnostics, Inc
Mar 8, 2017 Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 te... Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... Class II Siemens Healthcare Diagnostics, Inc
Mar 6, 2017 Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Excha... Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mo... Class II Philips Electronics North America Corporation
Feb 24, 2017 HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536... HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si... Class I Philips North America, LLC
Feb 22, 2017 INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Strai... Incorrect device was packaged. Class II Ace Surgical Supply Co., Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (e... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e240... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIF... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Intr... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Jan 18, 2017 Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These ... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These compu... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed The... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These comp... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These co... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 17, 2017 Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 ... The monitor may not alarm appropriately for a pediatric or neonatal patient. Class II Philips Electronics North America Corporation
Jan 10, 2017 Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... Class II Siemens Healthcare Diagnostics, Inc
Jan 10, 2017 Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... Class II Siemens Healthcare Diagnostics, Inc
Jan 10, 2017 Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with... Class II Siemens Healthcare Diagnostics, Inc
Jan 7, 2017 Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyz... It was discovered under rare circumstances the LED warning light circuit could fail. If this happ... Class II Olympus Scientific Solutions Americas
Jan 4, 2017 ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Pro... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Nu... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 4, 2017 IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material... DHEA-S causes falsely elevated progesterone results. Class II Siemens Healthcare Diagnostics, Inc
Jan 3, 2017 Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usag... During use, there is a potential scenario which could allow the fastening screws attaching covers... Class II Allen Medical Systems, Inc.
Dec 27, 2016 Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with In... May experience a loss of centralized monitoring. Class II Philips Electronics North America Corporation
Dec 21, 2016 AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 Fresenius 2008K Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016 DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, 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.