Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Date	Product	Reason	Class	Firm
Dec 20, 2018	Phoenix AP AST Indicator Bag, Catalog Number 246006	Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ...	Class II	Becton Dickinson & Co.
Dec 20, 2018	Phoenix AST Indicator, Catalog Number 246004	Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ...	Class II	Becton Dickinson & Co.
Dec 20, 2018	CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The C...	Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customer...	Class I	TERRIFIC CARE LLC
Dec 20, 2018	Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30...	Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) ...	Class II	Abbott Gmbh & Co. KG
Dec 20, 2018	AMSCO 3000 Series Washer/Disinfector Model # 3052	The software in the systems may not process the cycle originally intended. This could result in d...	Class II	Steris Corporation
Dec 20, 2018	AMSCO 5000 Series Washer/Disinfector Model # 5052	The software in the systems may not process the cycle originally intended. This could result in d...	Class II	Steris Corporation
Dec 20, 2018	GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Uni...	When switching back & forth between multiple UV instances in the Windows taskbar, the patient im...	Class II	GE Healthcare, LLC
Dec 19, 2018	Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034...	This recall has been initiated due to a change in packaging and sterilization method to address p...	Class II	XTANT MEDICAL INC
Dec 19, 2018	ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800	Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access...	Class II	Arjohuntleigh Magog
Dec 19, 2018	Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b...	A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.	Class II	Boston Scientific Corporation
Dec 19, 2018	Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a poteas...	The kits may contain the incorrect number of components or the kits may be missing components.	Class II	Associates of Cape Cod, Inc.
Dec 19, 2018	Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, ...	There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu...	Class II	Cook Inc.
Dec 19, 2018	Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, ...	There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu...	Class II	Cook Inc.
Dec 19, 2018	Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340...	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.	Class II	Reckitt Benckiser LLC
Dec 19, 2018	Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn...	A software update is being issued to correct multiple issues identified in the previous software ...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 19, 2018	Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: ...	Evidence supports that when customers performed a fuse replacement as part of a March 2017 field ...	Class II	Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Dec 19, 2018	Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-987...	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.	Class II	Reckitt Benckiser LLC
Dec 18, 2018	Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)	Product was packaged with the Incorrect tamper proof battery door.	Class II	Cochlear Americas Inc.
Dec 18, 2018	Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga ...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical i...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical inst...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instr...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: ...	There is a potential for a communication interruption following a bolus command that may result i...	Class II	Insulet Corporation
Dec 18, 2018	COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4S...	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ...	Class II	Wilson-Cook Medical Inc.
Dec 18, 2018	COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with ...	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ...	Class II	Wilson-Cook Medical Inc.
Dec 18, 2018	PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr...	The sutures inside the packaging are not the same size or type as indicated on the label.	Class II	Ethicon, Inc.
Dec 18, 2018	Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018	Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product ...	Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal...	Class II	Angiotech (Manan Medical Products, Inc.)
Dec 17, 2018	Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 035...	New endogenous interference claims have been established for the following assays used on the cob...	Class II	Roche Diagnostics Corporation
Dec 17, 2018	DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric ...	Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.	Class II	DeRoyal Industries Inc
Dec 17, 2018	Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roc...	Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 mo...	Class II	Roche Diagnostics Corporation
Dec 17, 2018	Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795...	New endogenous interference claims have been established for the following assays used on the cob...	Class II	Roche Diagnostics Corporation
Dec 17, 2018	Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscop...	The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af...	Class II	Olympus Corporation of the Americas
Dec 17, 2018	Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscop...	The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af...	Class II	Olympus Corporation of the Americas
Dec 17, 2018	BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnos...	Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating ...	Class II	Stryker Sustainability Solutions
Dec 17, 2018	Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended...	The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af...	Class II	Olympus Corporation of the Americas
Dec 17, 2018	Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are in...	The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af...	Class II	Olympus Corporation of the Americas
Dec 17, 2018	Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***add...	New endogenous interference claims have been established for the following assays used on the cob...	Class II	Roche Diagnostics Corporation
Dec 17, 2018	PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PR...	An enzyme reagent included in the kit is not maintaining stability through claimed product expira...	Class II	Meridian Bioscience Inc
Dec 14, 2018	MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjun...	If the head mount knob is not properly tightened and the operator directly uses the injector head...	Class II	Bayer Medical Care, Inc.
Dec 14, 2018	cobas c 111 with ISE analyzers analyzer used in the following assays: a)Crea...	COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and...	Class II	Roche Diagnostics Corporation
Dec 14, 2018	Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: ...	The product is contaminated with Pseudomonas.	Class II	Madison Polymeric Engineering
Dec 14, 2018	COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant A...	COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and...	Class II	Roche Diagnostics Corporation
Dec 14, 2018	Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter ...	Incorrect (higher) Rated Burst Pressure information printed on label.	Class II	BrosMed Medical Co.,Ltd.
Dec 13, 2018	SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Produc...	potential for urine leakage around the vent on the vented sample port	Class II	Bard Medical Division
Dec 13, 2018	Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2...	Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ...	Class II	Arrow International Inc
Dec 13, 2018	VITEK 2 AST-N351 Test Kit	False Positive ESBL Phenotype	Class II	bioMerieux, Inc.
Dec 13, 2018	Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2...	Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ...	Class II	Arrow International Inc
Dec 13, 2018	MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology in...	There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, whi...	Class II	Elekta, 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.