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
May 20, 2019	Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P...	Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig...	Class II	Maquet Cardiovascular Us Sales, Llc
May 20, 2019	Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr...	Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 28, 2019	SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe...	Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu...	Class I	Becton Dickinson & Company
Dec 12, 2018	Dimension Vista 500, Analyzer, chemistry Model no. 10284473	When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 12, 2018	Dimension Vista 1500, Analyzer, chemistry Model no. 10444801	When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi...	Potential compromise of product sterility due to breach of sterile barrier.	Class II	Medical Action Industries Inc
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 9, 2018	AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25...	Beckman Coulter has identified a case where a customer using the microltiterplate kit option with...	Class II	Beckman Coulter Inc.
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 18, 2018	HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Cat...	Incorrect measurement results caused by microbial contamination of the product, results in values...	Class II	EUROTROL INC
Oct 18, 2018	HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Ca...	Incorrect measurement results caused by microbial contamination of the product, results in values...	Class II	EUROTROL INC
Oct 16, 2018	Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 16, 2018	Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 12, 2018	Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128	This recall has been initiated in response to a seal defect found in certain sterile barrier pouc...	Class II	Atrium Medical Corporation
Oct 10, 2018	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f...	Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of...	Class II	Baxter Healthcare Corporation
Sep 18, 2018	The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A param...	Cross contamination may have occurred between wells for the reagent pack. As a result of this def...	Class II	Beckman Coulter Inc.
Sep 14, 2018	Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx S...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Aug 23, 2018	AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated...	The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label...	Class II	Tosoh Bioscience Inc
Jul 16, 2018	Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cob...	Sample material may potentially come in contact with the pipetting nozzle during operation of cob...	Class II	Roche Diagnostics Corporation
Jun 21, 2018	BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium pro...	A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an i...	Class II	Becton Dickinson & Co.
Jun 15, 2018	Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number ...	Potential proplylene glycol contamination	Class II	Covidien LLC
May 2, 2018	MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24...	Cross-contamination of samples has been reported when running the existing protocol on the system...	Class II	Roche Molecular Systems, Inc.
Apr 20, 2018	Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz;...	Firm is notifying customers that the Deep-Cleaning Service is now available in the United States....	Class II	LivaNova USA
Apr 16, 2018	BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm,...	Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo...	Class II	Bard Peripheral Vascular Inc
Apr 16, 2018	BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm,...	Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo...	Class II	Bard Peripheral Vascular Inc
Apr 11, 2018	Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 -...	Product sterility may be compromised due to unsealed packaging.	Class II	Arrow International Inc
Mar 21, 2018	Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic D...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endo...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flex...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 2, 2018	Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI83...	Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instrume...	Class II	Randox Laboratories Ltd.
Feb 8, 2018	J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-...	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec...	Class II	Bovie Medical Corporation
Feb 8, 2018	J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec...	Class II	Bovie Medical Corporation
Feb 8, 2018	J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec...	Class II	Bovie Medical Corporation
Feb 8, 2018	J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330...	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec...	Class II	Bovie Medical Corporation
Feb 8, 2018	J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BV...	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec...	Class II	Bovie Medical Corporation

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.