Browse Device Recalls

93 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 93 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 93 FDA device recalls in 2009.

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DateProductReasonClassFirm
Dec 29, 2009 Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV53... In the vast majority of products specified, a shrinkage of the air chamber during sterilization h... Class II Spiegelberg Gmbh & Co. KG
Dec 14, 2009 Xoran MiniCAT CT Scanner ID ENT00001 Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but ... Class II Xoran Technologies, Inc.
Nov 30, 2009 Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-8... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 2... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 20, 2009 Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 20... The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to i... Class II CareFusion Corporation
Nov 19, 2009 Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface,... The recall was initiated because Sunquest Information System has confirmed reports of an Outbound... Class II Sunquest Information Systems, Inc.
Nov 17, 2009 CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for cathet... The recall was initiated because Biosense Webster has become aware of information regarding a pot... Class II Biosense Webster, Inc.
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.
Nov 6, 2009 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed ... GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer com... Class II GE OEC Medical Systems, Inc
Oct 2, 2009 Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservo... Backplate reservoir holders were manufactured with an incorrect configuration of connector suppor... Class II Terumo Cardiovascular Systems Corporation
Sep 17, 2009 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Aug 12, 2009 Safety monitor included with System 8000 Base The Sarns" Modular Perfusion... Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai ... Class II Terumo Cardiovascular Systems Corporation
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 21, 2009 Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l... Class III Medtest Holdings, Inc.
Jul 13, 2009 Whole Body X--ray Scanner This device is indicated as a whole body volume ... 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw dat... Class II Toshiba American Medical Systems Inc
Jun 22, 2009 OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); I... GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated... Class I GE OEC Medical Systems, Inc
Jun 9, 2009 NDI P7 Position Sensor, Stereotaxic Instrument Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras)... Class II Orthosoft, Inc. dba Zimmer CAS
Jun 4, 2009 Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modu... Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Scre... Class II Atlas Spine, Inc.
Jun 1, 2009 Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
May 28, 2009 Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T... Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices becaus... Class II Alere San Diego, Inc.
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, 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.