Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Mar 22, 2017 Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065... ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detac... Class I ReFlow Medical
Mar 22, 2017 PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH,... This lot of left plates were laser etched and packaged as right plates. Class II Smith & Nephew, Inc.
Mar 22, 2017 UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNI... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 22, 2017 Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endova... There have been five reports of graft thrombosis/occlusion during global commercial use, each fo... Class I Cook Medical Incorporated
Mar 22, 2017 NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 22, 2017 Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM... pegs shearing post-operatively Class II Zimmer Biomet, Inc.
Mar 22, 2017 The following systems are only affected if a Laird chiller is installed (11NC... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 21, 2017 Dimension Troponin 1 (TNI) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Ferritin (FERR) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Estradiol (E2) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Digoxin (DIGXN) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Prolactin (PRL) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... Class II Roche Diagnostics Corporation
Mar 21, 2017 Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Proteus 235, Proton Therapy System In specific circumstances, the user is able to restart an aborted irradiation without having to s... Class II Ion Beam Applications S.A.
Mar 20, 2017 Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue Fl... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Art... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lu... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ A... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral H... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Prod... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Periphe... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterizatio... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central V... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arterial Catheterization Kit The Arrow¿ Arterial Catheterization device perm... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous C... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Pe... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheter... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Tapered SwissPlus Implant System, Model No. SPB10 It was manufactured with the minor diameter of the internal thread that is below specification. Class II Zimmer Dental Inc
Mar 20, 2017 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral H... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterizatio... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Art... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the c... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Periphe... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access D... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lume... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue F... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access De... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue Fl... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port f... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the c... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High ... The large-bore two-lumen catheter permits venous access to the central circulation for rapid flui... Class II Arrow International Inc
Mar 20, 2017 Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard B... The large-bore two-lumen catheter permits venous access to the central circulation for rapid flui... Class II Arrow International Inc
Mar 20, 2017 ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lum... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow 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.