Browse Device Recalls

960 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 960 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 960 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 19, 2018	AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125...	Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing pr...	Class II	Beckman Coulter Inc.
Jan 18, 2018	AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standar...	A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to caus...	Class II	Beckman Coulter Inc.
Dec 11, 2017	Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us...	Contamination with Methylbacterium thiocyanatum	Class II	Sanofi Genzyme
Nov 3, 2017	First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c...	Affected lots may have exceeded its microbial limits.	Class II	Madison Polymeric Engineering
Sep 28, 2017	Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator	Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will...	Class II	Philips Electronics North America Corporation
Jul 27, 2017	Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in...	A leak may allow for microbial contamination of the sterile fluid path.	Class II	Baxter Healthcare Corporation
Jul 17, 2017	Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon...	Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s...	Class II	Covidien LP
Jun 27, 2017	Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE...	Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ...	Class II	Cardinal Health 200, LLC
Jun 27, 2017	Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car...	Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ...	Class II	Cardinal Health 200, LLC
Jun 6, 2017	Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat...	Real-time shelf life testing failed at 24 months	Class II	Microbiologics Inc
May 22, 2017	TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 ...	Listeria monocytogenes contamination of non-sterile plated media	Class II	Becton Dickinson & Co.
May 9, 2017	Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidire...	a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the...	Class II	Roche Diagnostics Corporation
Apr 12, 2017	Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi...	The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the ...	Class II	Vascular Solutions, Inc.
Mar 24, 2017	Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel,...	Confirmed complaint of surface contamination of Listeria monocytogenes.	Class II	Remel Inc
Mar 1, 2017	Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx	Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co...	Class II	Roche Diagnostics Corporation
Mar 1, 2017	Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx	"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C...	Class II	Roche Diagnostics Corporation
Jan 23, 2017	Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-...	Sterility compromised due to breach in sterile barrier	Class II	Covidien LLC
Jan 23, 2017	Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe...	Sterility compromised due to breach in sterile barrier	Class II	Covidien LLC
Jan 5, 2017	Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte...	The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp...	Class II	PerkinElmer Life and Analytical Sciences, Walla...
Jan 5, 2017	Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ...	The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp...	Class II	PerkinElmer Life and Analytical Sciences, Walla...
Dec 14, 2016	SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recov...	Organ preservation fluid recalled due to potential for bacterial contamination.	Class II	Organ Recovery Systems, Inc.
Nov 23, 2016	Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ...	Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage...	Class II	Medline Industries Inc
Nov 9, 2016	Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Prod...	Drapes within the affected lots may include a manufacturing variation that prevents convenient re...	Class II	Halyard Health, Inc
Oct 31, 2016	Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2...	Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Pr...	Class II	Owens & Minor Distribution, Inc.
Oct 4, 2016	Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ...	Potential contamination with B. cepacia.	Class I	Nurse Assist, Inc
Sep 27, 2016	Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temper...	There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ...	Class II	Maquet Cardiovascular Us Sales, Llc
Sep 25, 2016	FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch"...	The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a full...	Class II	Lumenis Limited
Sep 2, 2016	HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD th...	Labeling inconsistency	Class II	Arrow International Inc
Aug 10, 2016	Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Jul 8, 2016	Diamond Coated Tips and Burs are accessories to the air powered Bone drill (V...	Through an error, the labeling failed to include the symbol or other text indicating that the di...	Class II	Nakanishi Inc.
Jul 8, 2016	Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS...	Through an error, the labeling failed to include the symbol or other text indicating that the di...	Class II	Nakanishi Inc.
Jul 8, 2016	Diamond Coated Tips and Burs are accessories to the air powered dental handpi...	Through an error, the labeling failed to include the symbol or other text indicating that the di...	Class II	Nakanishi Inc.
Jun 24, 2016	Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-...	Potential coating contamination with glass particles.	Class I	Cook Inc.
Jun 13, 2016	Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 a...	potential contamination with potassium hydroxide may have an impact when performing immunohistoch...	Class II	Richard-Allan Scientific Company
May 9, 2016	Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal ...	The device was found to have bacterial contamination.	Class II	Immuno-Mycologics, Inc
Apr 21, 2016	Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indica...	AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an...	Class II	Musculoskeletal Transplant Foundation, Inc.
Mar 30, 2016	AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./...	The product lot did not meet sterility requirements based on FDA sampling and analysis.	Class II	Amd-Ritmed, Inc.
Feb 24, 2016	IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reo...	Product does not meet sterility requirements based on FDA analysis and tested positive for Bacter...	Class II	Amd Ritmed
Feb 10, 2016	Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternat...	Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovere...	Class II	Ambu Inc.
Nov 30, 2015	Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is us...	Contamination of product with possible Bacillus spp	Class II	Acumedia Manufacturers, Inc.
Nov 18, 2015	FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A f...	The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fung...	Class II	Hardy Diagnostics
Nov 17, 2015	MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt...	MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer...	Class II	Owens & Minor Distribution, Inc.
Nov 17, 2015	MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt...	MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer...	Class II	Owens & Minor Distribution, Inc.
Nov 17, 2015	MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt...	MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer...	Class II	Owens & Minor Distribution, 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.
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 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.
Oct 30, 2015	BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5...	Three lots of CD64 (MD22) are contaminated with CD4 antibody.	Class II	Becton, Dickinson and Company, BD Biosciences
Sep 30, 2015	Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s...	For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies ...	Class II	O-Two Medical Technologies, Inc.
Jul 23, 2015	Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product...	customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC...	Class II	Siemens Healthcare Diagnostics, 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.