Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

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Date	Product	Reason	Class	Firm
Nov 16, 2015	RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	DrugSmart 9 Test Cup (BUP), Item No. 60960D	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	EDI BZO Uncut Sheet - Cup*, Item No. 160170	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 3, 2015	MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Nov 3, 2015	MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. ...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Nov 3, 2015	MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection o...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Oct 28, 2015	DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to mea...	Device is not functioning as intended: Two wires running to the ECG distribution circuit board a...	Class III	BC Group International Inc
Oct 27, 2015	Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS...	It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - ...	Class III	Lab Vision Corporation
Oct 2, 2015	Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i...	Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet...	Class III	C.R. Bard, Inc.
Sep 30, 2015	BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a...	Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.	Class III	Becton, Dickinson and Company, BD Biosciences
Sep 28, 2015	VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 85...	The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes ...	Class III	Ortho-Clinical Diagnostics
Sep 14, 2015	CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Pr...	CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels wh...	Class III	Biochemical Diagnostics Inc
Sep 14, 2015	MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ...	The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin...	Class III	CooperSurgical, Inc.
Sep 11, 2015	Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ...	Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe...	Class III	Acumedia Manufacturers, Inc.
Sep 3, 2015	AMSCO 400 and AMSCO C Small Steam Sterilizers	In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadver...	Class III	Steris Corporation
Sep 1, 2015	CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Elect...	Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains ...	Class III	CooperSurgical, Inc.
Aug 27, 2015	Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u...	Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned c...	Class III	Alere San Diego, Inc.
Aug 27, 2015	CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata...	CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.	Class III	Becton, Dickinson and Company, BD Biosciences
Aug 12, 2015	FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:...	The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship...	Class III	Abbott Electrophysiology
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	Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N...	Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com...	Class III	Cepheid
Jul 27, 2015	Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi...	Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com...	Class III	Cepheid
Jul 17, 2015	LYFO Disk	LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat...	Class III	Microbiologics Inc
Jun 29, 2015	Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat...	Loud operating sounds, which was unacceptable to the end users when the device was powered on. Th...	Class III	Baxter Healthcare Corp.
Jun 26, 2015	Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8...	Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated...	Class III	Getinge Disinfection Ab
Jun 23, 2015	BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. ...	Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifi...	Class III	Becton Dickinson & Company
Jun 17, 2015	Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags inc...	Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.	Class III	Acon Laboratories, Inc.
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	PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T...	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o...	Class III	Bard Access Systems
May 27, 2015	PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra...	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o...	Class III	Bard Access Systems
May 27, 2015	PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single...	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o...	Class III	Bard Access Systems
May 27, 2015	PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ...	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o...	Class III	Bard Access Systems
May 13, 2015	The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 261...	The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the exp...	Class III	Bio-Rad Laboratories, Inc.
May 6, 2015	D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA ...	Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.	Class III	Biocare Medical, LLC
May 6, 2015	VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique...	The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab...	Class III	ORTHO-CLINICAL DIAGNOSTICS
Apr 28, 2015	RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U...	Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's ...	Class III	Acclarent, Inc.
Apr 21, 2015	Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer...	Devices were placed in a shipper carton without the appropriate number of the Instructions for Us...	Class III	Zimmer Surgical Inc
Apr 16, 2015	Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6...	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i...	Class III	Biomet, Inc.
Apr 16, 2015	Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M...	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i...	Class III	Biomet, Inc.
Apr 16, 2015	Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T...	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i...	Class III	Biomet, Inc.
Apr 16, 2015	MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80...	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i...	Class III	Biomet, Inc.
Apr 9, 2015	Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ...	Some rods may not meet the appropriate traceability requirements including the lot number. Some ...	Class III	Spinal Elements, Inc
Mar 27, 2015	BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (G...	BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophil...	Class III	Becton Dickinson & Co.
Mar 25, 2015	Universal Charger Product Usage: The Stryker Universal Battery Charg...	The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi...	Class III	Stryker Instruments Div. of Stryker Corporation
Mar 13, 2015	Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ...	Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ...	Class III	Pointe Scientific, 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.