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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
May 29, 2019 Liberty Cycler Cassettes (a disposable cassette that is intended to be used t... Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler... Class II Fresenius Medical Care Renal Therapies Group, LLC
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
May 29, 2019 Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro ... Potential for increased rate of false positive results and/or increased rate of random non-repeat... Class II Siemens Healthcare Diagnostics Inc
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- Fo... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747... Packaged dental implant healing abutments were found to contain the wrong size device. Class II Nobel Biocare Usa Llc
May 28, 2019 Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Pa... The device was distributed with the outer carton labeled with the manufacture date and the expiry... Class II Datascope Corporation
May 28, 2019 Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage:... Potential for tube leakage Class II InfuTronix LLC
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:V... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: V... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:V... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VL... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VL... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) an... Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation... Class II Bio-Detek, Inc.
May 28, 2019 SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 28, 2019 The ICS CHARTR EP 200 There is a risk to the healthcare professional or patient of exposure to undergrounded electrical... Class II GN Otometrics
May 28, 2019 K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Expre... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: The... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: Th... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: ... Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... Class II Maquet Cardiovascular Us Sales, Llc
May 24, 2019 Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b)... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Ca... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm,... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tub... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Trachea... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 24, 2019 Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Pro... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5... This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... Class I Teleflex Medical
May 24, 2019 ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 23, 2019 E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is pl... E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Li... Class II Richard Wolf Medical Instruments Corp.
May 23, 2019 Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software v... During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscr... Class II Obalon Therapeutics Inc
May 23, 2019 Various products which were contract sterilized. The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. Class II Anewmed Corporation
May 23, 2019 DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug ... The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S.... Class II Leventon S. A. U.
May 22, 2019 "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR... Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma... Class II Abbott Laboratories

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.