Browse Device Recalls

917 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 917 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 917 FDA device recalls in MO.

Clear

Date	Product	Reason	Class	Firm
Jan 9, 2017	Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of ...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens San...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Sant...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Sant...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Cen...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center...	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 9, 2017	Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills	Custom procedure trays contain a component, a light glove, that has been recalled by the manufact...	Class II	Resource Optimization & Innovation Llc
Jan 1, 2017	Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, ...	The microscope may tip over if attachments are fully extended in one line and there is an attempt...	Class II	Seiler Instr. & Mfg. Co. Inc.
Dec 28, 2016	Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered ...	Powdered Surgical Gloves are an FDA banned substance.	Class II	American Contract Systems, Inc.
Sep 2, 2016	2000 Vascular with 30 Degree option	Potential for bed to drop suddenly at the head while a patient is laying on it.	Class II	Heritage Medical Products, Inc.
Aug 30, 2016	Carry bar which is an accessory to a lift used for patients in hospitals and ...	The black plastic puck on the carry bar is breaking resulting in potential for patient harm.	Class II	ErgoSafe Products, LLC (DBA) Prism Medical
Aug 11, 2016	25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part...	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec...	Class II	Synergetics Inc
Aug 11, 2016	25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged ...	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec...	Class II	Synergetics Inc
Aug 11, 2016	25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Prod...	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec...	Class II	Synergetics Inc
Aug 11, 2016	25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 700...	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec...	Class II	Synergetics Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca...	Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a...	Class II	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 11, 2016	USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Di...	Product may kink during use rendering the product unusable.	Class II	Us Endovascular
Dec 23, 2015	Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Ca...	One complaint of a seat on a scale failing unexpectedly which can cause an injury.	Class II	Cardinal Scale Mfg Co
Dec 1, 2015	CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively...	Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood...	Class II	Partners In Medicine Llc
Nov 23, 2015	Granada Biphasic Broth The product is a selective medium for the screening...	FDA has determined that the product requires 510(k) clearance to continue marketing/distribution ...	Class II	Biomerieux 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
Sep 8, 2015	Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053...	Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling...	Class II	ErgoSafe Products, LLC (DBA) Prism Medical
Sep 8, 2015	Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; w...	Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling...	Class II	ErgoSafe Products, LLC (DBA) Prism Medical
Aug 25, 2015	Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki...	Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d...	Class II	Resource Optimization & Innovation Llc
Aug 25, 2015	Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki...	Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d...	Class II	Resource Optimization & Innovation Llc
Aug 25, 2015	Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom pro...	The kits contain pressure monitoring kits or sets which are being recalled as a result of flow re...	Class II	Resource Optimization & Innovation Llc
Aug 25, 2015	Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k...	Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d...	Class II	Resource Optimization & Innovation Llc

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.