Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 5, 2015	The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme...	The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm ...	Class III	Leica Microsystems, Inc.
Jul 27, 2015	The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ...	The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty du...	Class II	Leica Microsystems, Inc.
Jul 20, 2015	Neptune 2 Waste Management System Docking Station (120V and 230V), New and Re...	The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be ...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 10, 2015	Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T...	Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ...	Class II	Stryker Sustainability Solutions
Jun 30, 2015	PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper b...	A reagent present may produce weak or slow reactions; continued use may result in a failure to id...	Class II	Remel Inc
Jun 30, 2015	PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex ...	A reagent present may produce weak or slow reactions; continued use may result in a failure to id...	Class II	Remel Inc
Jun 24, 2015	HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ...	Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.	Class II	Hardy Diagnostics
Jun 15, 2015	BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B...	Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th...	Class III	BD Biosciences, Systems & Reagents
May 27, 2015	DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm...	certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0...	Class II	Synthes, Inc.
May 22, 2015	0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (...	Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to compla...	Class II	Stryker Instruments Div. of Stryker Corporation
May 13, 2015	Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientif...	Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in t...	Class II	The Binding Site Group, Ltd.
May 4, 2015	Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P...	Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Se...	Class II	Smiths Medical Asd Inc
Mar 25, 2015	Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin wit...	Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT ...	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 17, 2015	CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage...	A drop in staining intensity over time has been observed. These lots may not meet their labeled s...	Class II	Biocare Medical, LLC
Feb 26, 2015	ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ...	During an internal inspection of the production process the firm discovered an issue which may ca...	Class II	Ethicon Endo-Surgery Inc
Feb 4, 2015	NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz...	One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.	Class II	Zimmer Trabecular Metal Technology, Inc.
Jan 7, 2015	Cold Therapy Pad - cold water circulating pad, one unit per package. The pa...	Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead t...	Class II	Cincinnati Sub-Zero Products Inc
Dec 16, 2014	Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh...	The staining intensity decreases over the shelf life.	Class II	Leica Microsystems, Inc.
Dec 8, 2014	Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ...	Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse...	Class II	Baxter Healthcare Corp.
Nov 26, 2014	SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10,...	Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report se...	Class II	SCC Soft Computer
Nov 21, 2014	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company....	Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prio...	Class II	Instrumentation Laboratory Co.
Nov 21, 2014	Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ...	Affected product may have compromised sterility due to packaging defects. It was determined that ...	Class II	Atricure Inc
Oct 23, 2014	Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests ...	A reagent within the test may return false negative results.	Class II	Remel Inc
Oct 8, 2014	Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in ...	Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for ...	Class II	Edwards Lifesciences, LLC
Sep 24, 2014	Foot Switches used with the following systems: Philips Allura Xper Systems; 7...	Loss of key image functionality due to a bent pedal of the Footswitch.	Class II	Philips Medical Systems, Inc.
Sep 16, 2014	Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ...	Particulate matter found inside the fluid path.	Class I	Baxter Healthcare Corp
Sep 16, 2014	Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen...	Particulate matter found inside the fluid path.	Class I	Baxter Healthcare Corp
Aug 15, 2014	Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser...	Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) becau...	Class II	Lumenis, Inc.
Aug 13, 2014	JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ...	BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th...	Class III	Biofire Defense
Aug 12, 2014	The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Aug 12, 2014	The Siemens Symbia T series is intended for use by appropriately trained heal...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Aug 12, 2014	The Siemens Symbia S series is intended for use by appropriately trained heal...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Jul 31, 2014	CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira...	The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp...	Class II	Carefusion 2200 Inc
Jul 14, 2014	*BaxterBURETROL Solution Set105" (2.7 m) 150 mL Burette*Drip Chamb...	Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut...	Class II	Baxter Healthcare Corp
Jul 14, 2014	*BaxterNon-DEHPBURETROL Solution Set 105" (2.7 m), 150 mL Burette*...	Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut...	Class II	Baxter Healthcare Corp
Jul 14, 2014	*BaxterBuretrol Solution Set105" (2.7 m)150 mL Burette**Drip Cham...	Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut...	Class II	Baxter Healthcare Corp
Jun 6, 2014	TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar ...	A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st...	Class II	Becton Dickinson & Co.
Jun 5, 2014	Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Tripl...	There is a potential for a leak. A molding defect in the connector that joins the three leads t...	Class II	Excelsior Medical Corp
May 20, 2014	LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE U...	Customed has determined that there is the possibility that packaging integrity may be compromised...	Class I	Customed, Inc
May 20, 2014	Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER ...	Customed has determined that there is the possibility that packaging integrity may be compromised...	Class I	Customed, Inc
May 20, 2014	LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND...	Customed has determined that there is the possibility that packaging integrity may be compromised...	Class I	Customed, Inc
May 20, 2014	LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW...	Customed has determined that there is the possibility that packaging integrity may be compromised...	Class I	Customed, Inc
May 8, 2014	MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. Th...	ConMed Corporation has received complaints regarding sparking, no output and burning at the cord ...	Class II	ConMed Corporation
Apr 30, 2014	PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or...	Difficulty removing the cup adaptor from the impaction handle during surgery	Class II	Microport Orthopedics INC.
Apr 28, 2014	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ...	Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks...	Class II	Baxter Healthcare Corporation
Apr 18, 2014	Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t...	Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d...	Class II	Leica Microsystems, Inc.
Apr 3, 2014	iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul...	Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb...	Class II	Boston Scientific Corporation
Mar 7, 2014	Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc...	One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp whi...	Class II	Clarity Medical Systems Inc
Mar 3, 2014	Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length S...	Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I...	Class II	Biocardia, Inc.
Mar 3, 2014	Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: ...	Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I...	Class II	Biocardia, 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.