Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

Date	Product	Reason	Class	Firm
Dec 22, 2023	Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO	Sterility assurance for saline included in surgical kits cannot be guaranteed.	Class I	Windstone Medical Packaging, Inc.
Dec 21, 2023	MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600	Due to, during the manufacturing process, the prescribed manufacturing and quality processes were...	Class II	MICROVENTION INC.
Dec 21, 2023	Phantom TTC Nail, 10.0 X 200mm, Right	Medical devices distributed, prior to sterilization	Class II	Paragon 28, Inc.
Dec 21, 2023	HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570...	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 21, 2023	Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ...	Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e...	Class II	Covidien LP
Dec 21, 2023	MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L	Medical devices distributed, prior to sterilization	Class II	Paragon 28, Inc.
Dec 21, 2023	Article No. NA6050411, Valiant PhD No. 1 Econo	Affected product may not perform as expected; the amalgam powder may not triturate correctly and ...	Class II	Ivoclar Vivadent, Inc.
Dec 21, 2023	Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R	Medical devices distributed, prior to sterilization	Class II	Paragon 28, Inc.
Dec 21, 2023	MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t...	Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati...	Class II	G & H Wire Company
Dec 21, 2023	MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Caniste...	The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ...	Class II	Cardinal Health 200, LLC
Dec 21, 2023	Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Caniste...	The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ...	Class II	Cardinal Health 200, LLC
Dec 21, 2023	HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 21, 2023	MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla...	Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious det...	Class II	Medagent Inc
Dec 21, 2023	MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023	PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code ...	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 21, 2023	Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8...	Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e...	Class II	Covidien LP
Dec 21, 2023	CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510	The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ...	Class II	Cardinal Health 200, LLC
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), ...	The firm has become aware of a sudden increase in complaints for three associated lots. Performan...	Class II	CooperSurgical, Inc.
Dec 20, 2023	Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Suction Connector with ENFit, REF EN0066000	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou...	When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5...	Class II	Zyno Medical LLC
Dec 20, 2023	These wipes are saturated with 0.65% bleach solution. These wipes are antimic...	There is stability concern for products dated with a 24-month shelf life. Product is safe and eff...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Barco MDSC-8527 NXF, Part Number K9352421	Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch o...	Class II	Barco N.V.
Dec 20, 2023	Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Lopez Valve¿ with ENFit, REF EN0056000	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr...	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 20, 2023	Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi...	Class II	C.R. Bard Inc
Dec 19, 2023	Model A710 Intellis Clinician Programmer Application, version 2.0.97	Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ...	Class II	Medtronic Neuromodulation
Dec 19, 2023	EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ...	Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac...	Class II	Boston Scientific Corporation
Dec 19, 2023	Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medf...	Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part...	Class II	Smiths Medical ASD Inc.
Dec 19, 2023	REV 2 Flowcell Capsule Spare, Part Number: C04154	Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear...	Class II	Beckman Coulter, Inc.
Dec 19, 2023	Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following R...	Distribution without Pre-Market Clearance	Class II	Acumed LLC
Dec 19, 2023	Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 ...	Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part...	Class II	Smiths Medical ASD 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.