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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Mar 14, 2016 Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure u... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure u... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiog... After importing segmentation results of the left atrium created on the Artis One system, the poss... Class II Siemens Medical Solutions USA, Inc
Mar 11, 2016 Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product U... The units have been fitted with a potentially faulty power supply cable. Class II RESEARCH INSTRUMENTS LTD - SITE B
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 Pneumatic Impactor, General Surgery, With Microaire Hose Connector Profes... MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were sh... Class II MicroAire Surgical Instruments, LLC
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manu... One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may ... Class II Integra York PA, Inc
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only ... Integra's post QA release review of historical product release test results for Meshed IDRT produ... Class II Integra LifeSciences Corporation
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 10, 2016 Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reage... The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer rout... Class II Jas Diagnostics/Drew Scientific
Mar 10, 2016 Poly-bags containing the strap labeled with "Adult" sticker. Each strap ki... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 10, 2016 Poly-bags containing splint strap labeled with "Pediatric" sticker. Each s... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 10, 2016 ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... Class II Siemens Healthcare Diagnostics, Inc.
Mar 10, 2016 HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Mar 10, 2016 eCareCoordinator allows the customer to schedule patient tasks (i.e., take we... The adherence check generates a software error. Two issues occur as a result of the software err... Class II Philips Visicu
Mar 10, 2016 The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a m... If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the anal... Class II Merge Healthcare, Inc.
Mar 10, 2016 Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K an... Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Mar 10, 2016 Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Mar 9, 2016 Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog numbe... After performing the suctioning maneuver, including disconnecting the patient, suctioning , and r... Class II Hamilton Medical, Inc.
Mar 9, 2016 Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Mo... Panorama Central Station including the work station View Station, View Station and the eGateway w... Class II Mindray DS USA, Inc. dba Mindray North America
Mar 9, 2016 All instrumentation associated with the Prelude PF Resurfacing Knee System. Inadequate design control. Class II Biomet, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 35... The center bolt of the sling bar, which connects the bar to the patient lift, has failed during u... Class II Hill-Rom, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Dian... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, 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.