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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2017 | Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sh... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: ... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; ... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume In... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code:... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Oct 17, 2017 | Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue ... | These finished good kits may contain the incorrect Springwire Guide (SWG). | Class II | Arrow International Inc |
| Jul 25, 2017 | ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International Inc |
| Jul 25, 2017 | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International Inc |
| Jul 10, 2017 | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device p... | Needle supplier indicated the presence of loose polypropylene foreign matter above release specif... | Class II | Arrow International Inc |
| Jun 12, 2017 | Arrow Glide Thru Peel-Away Sheath/Dilator Introducer | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 12, 2017 | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and A... | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 1, 2017 | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central V... | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... | Class II | Arrow International Inc |
| Jun 1, 2017 | ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (... | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... | Class II | Arrow International Inc |
| Jun 1, 2017 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is in... | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... | Class II | Arrow International Inc |
| Jun 1, 2017 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is in... | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... | Class II | Arrow International Inc |
| May 9, 2017 | ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit veno... | The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment o... | Class II | Arrow International Inc |
| May 9, 2017 | Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device p... | The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment o... | Class II | Arrow International Inc |
| May 9, 2017 | Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for H... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blu... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pre... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Fea... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Lon... | The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to t... | Class II | Arrow International Inc |
| Apr 28, 2017 | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Cen... | Arrow International is notifying each customer who received the affected that product that the ki... | 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 | 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 | 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 |
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.