Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 |
| 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 |
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.