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 20, 2017 ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arr... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectab... 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 QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arteri... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous acces... 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. Peri... 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 PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Ar... 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 4 Fr. Periphe... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Arr... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectab... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Arrow Pressure Injectable PICC Kit The Arrow International Pressure Inject... 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 The ArrowEVOLUTION Pressure Injectabl... 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 CThe CG+Arrow JACC powe... 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 4 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 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 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 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) VPS(R) Access Kit for use with 5 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 ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7... 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 Two-Lumen C... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Cathet... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard ... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The A... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 20, 2017 ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology an... When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it ... Class II Roho Inc.
Mar 20, 2017 Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectab... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 17, 2017 VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) as... Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated e... Class II BioMerieux SA
Mar 17, 2017 DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead ... Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which c... Class II Medtronic Neuromodulation
Mar 17, 2017 GIZA Vertebral Body Replacement Complaints that implants have been disassembled by surgeons because of unscrewing completely the ... Class II Eden Spine Europe SA
Mar 17, 2017 Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheteri... Arrow International is recalling due to possible voids in the catheter hub, which could lead to a... Class II Arrow International Inc
Mar 17, 2017 CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO. Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yel... Class II Smiths Medical ASD Inc.
Mar 16, 2017 Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 Th... Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driv... Class II Zimmer Biomet Spine, Inc
Mar 16, 2017 Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, ... BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrat... Class II Becton Dickinson & Company
Mar 16, 2017 Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, 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.