Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Date	Product	Reason	Class	Firm
Nov 26, 2013	Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neu...	Integra became aware through a complaint from a single non-US customer that if the optional SYS/D...	Class II	Integra LifeSciences Corp.
Nov 26, 2013	REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M...	Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.	Class II	Materialise USA LLC
Nov 26, 2013	S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in ...	Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b...	Class II	Stryker Medical Division of Stryker Corporation
Nov 26, 2013	Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically fo...	Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b...	Class II	Stryker Medical Division of Stryker Corporation
Nov 26, 2013	InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assis...	GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENT...	Class II	GE OEC Medical Systems, Inc
Nov 26, 2013	outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin...	Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906...	Class II	Biomet, Inc.
Nov 26, 2013	UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay...	The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured...	Class II	Beckman Coulter Inc.
Nov 26, 2013	G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000	Investigation identified that the outer label, inner label, and patient label all have the incorr...	Class II	Biomet, Inc.
Nov 26, 2013	Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial...	Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits...	Class II	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Nov 26, 2013	BD Interlink threaded lock cannula This is a locking blunt plastic cannula s...	BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote...	Class II	Becton Dickinson & Company
Nov 26, 2013	STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be...	Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI...	Class II	Advanced Sterilization Products
Nov 25, 2013	DRX-Evolution with FF WS These products are permanently installed diagnost...	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an...	Class II	Carestream Health, Inc.
Nov 25, 2013	DRX-Evolution with CSH WS These products are permanently installed diagnos...	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an...	Class II	Carestream Health, Inc.
Nov 25, 2013	MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio...	This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume...	Class II	Roche Diagnostics Operations, Inc.
Nov 25, 2013	Viscocel and Viscocel Plus. These products are intraocular fluid devices c...	CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in ...	Class I	C.L.R. Medicals International, Inc.
Nov 25, 2013	Synergy XVI XVI can incorrectly calculate the target position of the treat...	XVI can incorrectly calculate the target position of the treatment table.	Class II	Elekta, Inc.
Nov 25, 2013	REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-5...	One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing th...	Class II	Smith & Nephew Inc
Nov 25, 2013	DR 7500 with FF WS These products are permanently installed diagnostic x-r...	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an...	Class II	Carestream Health, Inc.
Nov 25, 2013	HT Connect Peripheral Guide Wire Part Number Description 1012587 ...	Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small nu...	Class II	Abbott Vascular, Inc.
Nov 25, 2013	Agility. Version 3.1 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Synergy XVI The Elekta Synergy S is intended to be used for radiation ther...	Potential collision risk when using XVI and external beam shaping devices.	Class II	Elekta, Inc.
Nov 25, 2013	RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user in...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	XiO RTP System. Used to create treatment plans for any cancer patient for ...	When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Sourc...	Class II	Elekta, Inc.
Nov 25, 2013	Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti...	Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste...	Class II	Navilyst Medical, Inc.
Nov 25, 2013	Integrity. Version 1.1 of the Integrity interface and control software for t...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Desktop Pro TM linear accelerator control software intended to assist a licen...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	XiO RTP System The XiO RTP System is used to create treatment plans for an...	When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded...	Class II	Elekta, Inc.
Nov 25, 2013	Agility. Version 3.0 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 23, 2013	The Abbott m2000sp is an automated system for performing sample preparation f...	The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling a...	Class II	Abbott Molecular
Nov 22, 2013	4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. p...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. ...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 2...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. Un...	D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not b...	Class III	Bio-Rad Laboratories, Inc.
Nov 22, 2013	Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pu...	Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smi...	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. p...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. pe...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. p...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. ...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentrati...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. p...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 22, 2013	Pulmonary Hemi-Artery SG Used in heart surgery	Serological testing for the donor was performed with a blood sample that may have been hemodilute...	Class II	CryoLife, Inc.
Nov 22, 2013	4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per...	issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes	Class II	Smiths Medical ASD, Inc.
Nov 21, 2013	Medrad Veris MR Monitor units The system is intended to monitor physiolog...	The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and cou...	Class II	Medrad Mr Inc
Nov 21, 2013	The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. ...	Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 80...	Class II	Welch Allyn Protocol, Inc
Nov 21, 2013	Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fl...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 21, 2013	Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 21, 2013	Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoro...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging 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.