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.

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DateProductReasonClassFirm
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL F... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefil... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefill... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Pr... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes in... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 9, 2012 Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) The manufacturer informed the recalling firm of a potential laser marking error in size identific... Class II Aesculap, Inc.
May 3, 2012 Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... Class I Arrow International Inc
Apr 30, 2012 Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray s... During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira ... Class II Siemens Medical Solutions USA, Inc
Apr 30, 2012 Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Urosk... Class II Siemens Medical Solutions USA, Inc
Apr 27, 2012 Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy ... The specified Trilogy units are being recalled because of the potential for a faulty component in... Class I Respironics, Inc.
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump Syst... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for ... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristalti... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Standard Administration Kit Perista... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump ... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump Sy... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump ... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump Syst... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pum... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Secondary Administration Kit Perist... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 2, 2012 MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable... Product was packaged with the incorrect port and does not match the label. The kit is labeled as... Class II Medical Components, Inc dba MedComp
Mar 23, 2012 Infusomat(R) Space Pump (US Version) with software version 686G030103 (common... Firm became aware of the potential for breakage of the anti free flow clip catch, located on the ... Class I B. Braun Medical, Inc.
Mar 23, 2012 Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. ... Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters,... Class II B. Braun Medical, Inc.
Mar 7, 2012 S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision... Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput ... Class II Aesculap Implant Systems LLC
Feb 24, 2012 Siemens syngo.plaza. Radiological image processing system Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20... Class II Siemens Medical Solutions USA, Inc
Feb 21, 2012 Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Pr... During an internal quality inspection, the tibia plateau was found to be out of specification. T... Class II Aesculap Implant Systems
Jan 6, 2012 Hemostatic Bone Putty, for use as a water-soluble implant material and for u... Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead ... Class II Synthes, Inc.
Sep 6, 2011 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Calibration factors in the pump overwritten during a programming step. The force sensor could sen... Class II Animas Corporation
Aug 8, 2011 Siemens syngo.plaza image processing system image processing radiological ... The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" function... Class II Siemens Medical Solutions USA, Inc
Nov 26, 2010 Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. The main harness connector was manufactured without the required back shield sealing protection. ... Class II Pride Mobility Products Corp
Nov 10, 2009 Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: ... Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. T... Class II Olympus America Inc.
Mar 4, 2009 lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014... Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the ... Class II Invatec 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.