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.

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DateProductReasonClassFirm
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 7, 2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... Class II Aesculap Implant Systems LLC
Mar 6, 2017 Syngo.via, Picture archiving and communication system Syngo via is a softwar... Software changes now available to address several issues Class II Siemens Medical Solutions USA, Inc
Mar 6, 2017 Syngo.x, Picture archiving and communication system Syngo via is a software ... Software changes now available to address several issues Class II Siemens Medical Solutions USA, 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
Feb 27, 2017 Axiom Artis fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... Class II Siemens Medical Solutions USA, Inc
Feb 27, 2017 Artis Zee and Zeego fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... Class II Siemens Medical Solutions USA, Inc
Feb 27, 2017 Artis Q and Q.Zen fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2017 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states ... Class II Medical Components, Inc dba MedComp
Feb 22, 2017 ARTIS Q, Interventional Fluroscopic x-ray system In Artis systems with A100G generators, a component can be affected by aging which could result i... Class II Siemens Medical Solutions USA, Inc
Feb 20, 2017 Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... Software updates Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ARTISTE" MV System Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 Mevatron M2/Primus Mid-Energy PRIMUS HI Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Expression ONCOR" Impression ONCOR" Impression plus Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Avant-garde Software update Class II Siemens Medical Solutions USA, Inc
Feb 13, 2017 Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modul... Class II New Era Orthopaedics, LLc

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.