Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Nov 12, 2019	CIC Pro Clinical Information Center Central Station - Product Usage: The inte...	When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v...	Class II	GE Healthcare, LLC
Nov 12, 2019	ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is int...	When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v...	Class II	GE Healthcare, LLC
Nov 12, 2019	ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo...	Nonfunctional key due to the potential for damage to the key pins cause by force of use during as...	Class II	Aesculap Implant Systems LLC
Nov 11, 2019	Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST	Components 2mm shorter than indicated on the package label	Class II	Nextremity Solutions
Nov 11, 2019	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF...	A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm...	Class II	Abbott Medical
Nov 11, 2019	Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST	Components 2mm shorter than indicated on the package label	Class II	Nextremity Solutions
Nov 11, 2019	smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROF...	There is a a potential failure mode associated with the use of the mallet, wherein the poly tip o...	Class II	Smith & Nephew, Inc.
Nov 11, 2019	Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST	Components 2mm shorter than indicated on the package label	Class II	Nextremity Solutions
Nov 11, 2019	Medicrea International Universal Counter Torque for use with the Pass TULIP [...	Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)	Class II	Medicrea International
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H ...	Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's ...	Class II	Boston Scientific Corporation
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 7, 2019	Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless...	May have a missing locking wire causing delay in surgery while retrieving a back-up device or imp...	Class II	Howmedica Osteonics Corp.
Nov 7, 2019	iChem VELOCITY Urine Chemistry Analyzer	Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for th...	Class II	Beckman Coulter Inc.
Nov 7, 2019	Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot bra...	Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia	Class II	Neuronetrix Solutions, LLC dba Cognision
Nov 7, 2019	Ligamax 5 mm Endoscopic Multiple Clip Applier	A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in...	Class II	Ethicon Endo-Surgery Inc
Nov 7, 2019	ARCHITECT HAVAB-G Calibrator, REF 6L27-01	Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Rel...	Class II	Abbott Gmbh & Co. KG
Nov 6, 2019	The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitati...	The chemiluminescent immunoassay has been noted to have higher than expected results which may re...	Class II	Qualigen Inc
Nov 6, 2019	NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ...	The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-...	Class III	Allergan PLC
Nov 6, 2019	Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an...	The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-...	Class III	Allergan PLC
Nov 6, 2019	Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St...	The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-...	Class III	Allergan PLC
Nov 6, 2019	Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ...	The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-...	Class III	Allergan PLC
Nov 6, 2019	Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, P...	It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparis...	Class II	The Binding Site Group, Ltd.
Nov 6, 2019	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder...	There is a potential for the cuff to leak air leading to a loss of vascular occlusion.	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 6, 2019	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder...	There is a potential for the cuff to leak air leading to a loss of vascular occlusion.	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 5, 2019	Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer...	The Autostainer instrument may not have a syringe tray installed which could result in a small vo...	Class II	Dako Denmark A/S
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visuali...	Exhibiting a reversed image. Although the image may appear normal, the users actions will be reve...	Class I	King Systems Corp. dba Ambu, Inc.
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-...	Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric...	Class II	Avanos Medical, Inc.
Nov 4, 2019	Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through...	Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional co...	Class II	Medacta Usa Inc
Nov 4, 2019	Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apo...	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an...	Class II	Villa Sistemi Medicali S.P.A.
Nov 4, 2019	Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr...	False positive results due to potential contamination of reagent.	Class II	Immuno-Mycologics, Inc
Nov 4, 2019	Healix Knotless ADV BR 5.5 Suture Anchor	Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 4, 2019	Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ...	The indicator may show available charge when the battery is close to depletion. As a result, the ...	Class II	Becton Dickinson & Company
Nov 4, 2019	Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product...	Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa...	Class II	Integra Lifesciences Sales Llc
Nov 4, 2019	Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled ta...	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an...	Class II	Villa Sistemi Medicali S.P.A.
Nov 4, 2019	Trinias DAP Meter, a component of the Digital Anglo System Trinias contained ...	The DAP meters were found to be outside of tolerance.	Class II	Shimadzu Medical Systems
Nov 4, 2019	Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-cont...	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an...	Class II	Villa Sistemi Medicali S.P.A.
Nov 4, 2019	Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray ...	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an...	Class II	Villa Sistemi Medicali S.P.A.
Nov 4, 2019	8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: ...	The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain th...	Class II	Trilliant Surgical, LLC
Nov 4, 2019	Healix Knotless ADV BR 4.75 Suture Anchor	Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 1, 2019	BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Scre...	A new lot of ANA screen control and any subsequent control lots are incompatible with older lot n...	Class II	Bio-Rad Laboratories, Inc.
Oct 30, 2019	Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A	The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end...	Class II	Medline Industries 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.