Browse Device Recalls

478 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 478 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 478 FDA device recalls.

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DateProductReasonClassFirm
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
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 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 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 3, 2017 The CG+ Arrow PIC Catheters permit venous access to the central circulation t... Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithro... Class II Arrow International Inc
Jan 11, 2017 Vascular catheter introduction kit The PICC is indicated for short or long t... There have been complaints for peel away sheaths flaring Class II Arrow International Inc
Sep 2, 2016 HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD th... Labeling inconsistency Class II Arrow International Inc
Aug 8, 2016 Arterial Line Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Aug 8, 2016 Radial Artery Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Jul 7, 2016 Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is ... Arrow is recalling due to incorrect labeling of products. Class II Arrow International Inc
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS... Arrow is recalling these products due to the possibility that although the kit is labeled as cont... Class II Arrow International Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arr... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous acce... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An a... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Jan 12, 2016 Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... 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.