Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 25, 2017 | 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyuretha... | The kit was packaged with the incorrect introducer needle size. The label indicates the kit cont... | Class II | Medical Components, Inc dba MedComp |
| May 22, 2017 | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 1086317... | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. ... | Class II | Siemens Medical Solutions USA, Inc |
| May 16, 2017 | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 109... | Software error. In Sensis Vibe systems with software version VD10B, a software error can result ... | Class II | Siemens Medical Solutions USA, 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 |
| May 1, 2017 | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in t... | Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhi... | Class II | Circadiance LLC |
| 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 |
| Apr 19, 2017 | High Frequency Resection Electrodes, endoscope, ac-powered and accessories T... | Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. | Class II | Olympus Corporation of the Americas |
| Apr 12, 2017 | AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a... | An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Per... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 10, 2017 | CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units eac... | B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential f... | Class II | B Braun Medical Inc |
| Mar 28, 2017 | GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAM... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| Mar 28, 2017 | Artis zee, Angiographic x-ray system | Software error - As a result of a software fault in Artis zee systems with software version VD11 ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 28, 2017 | GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAM... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| Mar 28, 2017 | GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.D... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| 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 |
| 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 |
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.