Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

Clear

Date	Product	Reason	Class	Firm
Sep 20, 2012	STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are...	Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it...	Class II	Advanced Sterilization Products
Sep 20, 2012	GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 20, 2012	ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2	Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTR...	Class II	Horiba Instruments, Inc dba Horiba Medical
Sep 20, 2012	The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non ...	Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the...	Class II	Zimmer, Inc.
Sep 20, 2012	Medline Total Knee CDS; a single patient prescription procedure pack and disp...	The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pa...	Class II	Medline Industries Inc
Sep 20, 2012	The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. S...	Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missin...	Class II	Zimmer, Inc.
Sep 20, 2012	CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. ...	Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device premature...	Class II	Captiva Spine, Inc
Sep 20, 2012	Terumo Advanced Perfusion System 1 Flow Module indicated for use in extrac...	Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced ...	Class II	Terumo Cardiovascular Systems Corporation
Sep 20, 2012	SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 20, 2012	GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183...	GE Healthcare has recently become aware that patient mismatch without a warning message could occ...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of ...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 19, 2012	S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 Sys...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 19, 2012	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is d...	The firm initiated the product recall because labeling on some of the intermediate boxes of cathe...	Class II	Cure Medical LLC
Sep 19, 2012	S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 Sy...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 19, 2012	Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical...	Incidents regarding fractures of the front joint of the spring arm have been reported.	Class II	Trumpf Medical Systems, Inc.
Sep 19, 2012	Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ...	Firm received reports of difficulty in flushing the graft cover of the delivery system during dev...	Class II	Medtronic Vascular, Inc.
Sep 19, 2012	S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 ...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 19, 2012	S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 S...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 19, 2012	Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 S...	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o...	Class II	Sorin Group USA, Inc.
Sep 18, 2012	Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Num...	The firm initiated this recall because complaints from customers reported that the recovery comp...	Class II	Iris Diagnostics
Sep 18, 2012	CareStream Dental CS 2200 X-ray system Product Usage: The expected usage...	There have been approximately 2% of the x-ray generators manufactured between February 2012 and N...	Class II	Trophy Sas
Sep 18, 2012	Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blad...	Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which c...	Class II	Instratek, Incorporated
Sep 18, 2012	Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips...	The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents th...	Class II	Philips Medical Systems (Cleveland) Inc
Sep 18, 2012	CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The ex...	There have been approximately 2% of the x-ray generators manufactured between February 2012 and N...	Class II	Trophy Sas
Sep 18, 2012	CareStream Dental CS 2100 X-ray system Product Usage: The expected usage ...	There have been approximately 2% of the x-ray generators manufactured between February 2012 and N...	Class II	Trophy Sas
Sep 18, 2012	CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The ex...	There have been approximately 2% of the x-ray generators manufactured between February 2012 and N...	Class II	Trophy Sas
Sep 18, 2012	Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog ...	Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test resu...	Class II	Becton Dickinson & Co.
Sep 18, 2012	MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) u...	A patient was seriously mistreated after a user made and saved an inadvertent change to the defin...	Class II	Elekta, Inc.
Sep 17, 2012	Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, mono...	Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue...	Class II	Boston Scientific Corporation
Sep 17, 2012	Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLa...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	BariAir Therapy System The BariAir Therapy System is a risk management tre...	KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The Bari...	Class II	KCI USA, Inc.
Sep 17, 2012	Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These sy...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLa...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPID...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoi...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15)...	Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue...	Class II	Boston Scientific Corporation
Sep 17, 2012	Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical dev...	Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue...	Class II	Boston Scientific Corporation
Sep 17, 2012	Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These ...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 17, 2012	Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLa...	RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ...	Class II	Siemens Healthcare Diagnostics Inc
Sep 15, 2012	Centricity PACS System versions 3.X and higher and 4.X and higher Product Us...	There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra...	Class II	Ge Healthcare It
Sep 14, 2012	Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, ...	Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or ent...	Class II	Sorin Group USA, Inc.
Sep 14, 2012	Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, L...	Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or ent...	Class II	Sorin Group USA, Inc.
Sep 14, 2012	Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM,...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identific...	Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P...	Class II	Advandx Inc
Sep 14, 2012	Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicate...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, 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.