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 9, 2022	BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836...	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
May 9, 2022	BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company
Apr 21, 2022	MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE	Sporadic reports were received of discoloration on the foam sponge on certain lots of the product...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022	MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS	Sporadic reports were received of discoloration on the foam sponge on certain lots of the product...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022	MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS	Sporadic reports were received of discoloration on the foam sponge on certain lots of the product...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022	MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW	Sporadic reports were received of discoloration on the foam sponge on certain lots of the product...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022	MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS	Sporadic reports were received of discoloration on the foam sponge on certain lots of the product...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Mar 11, 2022	Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC...	ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ...	Class II	Total Resources Intl
Mar 11, 2022	Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT0...	ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ...	Class II	Total Resources Intl
Jan 31, 2022	Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis...	This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of...	Class II	B. Braun Medical, Inc.
Jan 21, 2022	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und...	A risk for product contamination was identified for the affected product lot. If used, there is a...	Class II	NeuMoDx Molecular Inc
Dec 28, 2021	Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin...	The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ...	Class II	Hobbs Medical, Inc.
Nov 19, 2021	Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455	A subset of affected discs are at risk of leakage when it is used more than one time with Simplex...	Class II	DiaSorin Molecular LLC
Nov 10, 2021	PIVO Blood Collection Device 20G, REF: 202-0005	Incomplete sealing of blood collection device unit packages may produce a breach in the sterile b...	Class II	Velano Vascular
Nov 2, 2021	EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V	Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope cont...	Class II	Olympus Corporation of the Americas
Oct 14, 2021	IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Lumenis, Inc.
Oct 11, 2021	BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 U...	Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results...	Class II	BioFire Diagnostics, LLC
Oct 11, 2021	Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive...	Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay	Class II	Clark Laboratories, Inc.
Sep 7, 2021	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	DJO, LLC
Sep 7, 2021	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	DJO, LLC
Aug 27, 2021	Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL;...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	North Coast Medical Inc
Aug 27, 2021	EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Descripti...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	North Coast Medical Inc
Aug 25, 2021	Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Accelerated Care Plus Corporation
Aug 24, 2021	ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmissio...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	National Distribution & Contracting Inc
Aug 24, 2021	ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	National Distribution & Contracting Inc
Aug 23, 2021	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in ac...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Aesthetics Systems Usa Inc
Aug 20, 2021	LiquaSonic Ultrasound Gel 5L, Model No. 001222	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Athena Medical Products Inc
Aug 20, 2021	LiquaSonic Ultrasound Gel 250mL, Model No. 001205	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Athena Medical Products Inc
Aug 18, 2021	Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultr...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Scrip Inc
Aug 18, 2021	Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultr...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Scrip Inc
Aug 12, 2021	EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiP...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	AMTEC SALES Inc
Aug 11, 2021	EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 11, 2021	EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 11, 2021	EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 4, 2021	Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Mac Medical Supply Co Inc
Jul 28, 2021	Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd

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.