Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 669 of 1191

FDA device recalls, page 669 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1042-2015	Class II	Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual...	Zimmer GmbH	JWH	2014-11-25
Z-0901-2015	Class II	SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg...	Nonin Medical, Inc	DQA	2014-11-25
Z-0800-2015	Class II	DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number...	Eastman Kodak Company	IZL	2014-11-25
Z-1366-2015	Class II	Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject...	Owen Mumford USA, Inc.	KZH	2014-11-24
Z-0946-2015	Class II	Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro...	Siemens Healthcare Diagnostics Inc.	JIT	2014-11-24
Z-1114-2015	Class II	Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number...	Arthrosurface, Inc.	HSD	2014-11-24
Z-1113-2015	Class II	Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875...	Arthrosurface, Inc.	HSD	2014-11-24
Z-1112-2015	Class II	Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032...	Arthrosurface, Inc.	HSD	2014-11-24
Z-1111-2015	Class II	Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035...	Arthrosurface, Inc.	HSD	2014-11-24
Z-1110-2015	Class II	Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028...	Arthrosurface, Inc.	HSD	2014-11-24
Z-2415-2015	Class II	Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile	Teleflex Medical	BTS	2014-11-21
Z-2414-2015	Class II	White Bronchial Double Lumen Tube Set (Right) Sterile	Teleflex Medical	BTS	2014-11-21
Z-2413-2015	Class II	Tracheopart Set (Right), Sterile	Teleflex Medical	BTS	2014-11-21
Z-2412-2015	Class II	Tracheopart Set (Left), Sterile	Teleflex Medical	BTS	2014-11-21
Z-2411-2015	Class II	Carlens Bronchial Double Lumen Tube Set (Left) Sterile	Teleflex Medical	BTS	2014-11-21
Z-2410-2015	Class II	Bronchial One Lumen Tube - Right	Teleflex Medical	BTS	2014-11-21
Z-2409-2015	Class II	Bronchial One Lumen Tube - Left	Teleflex Medical	BTS	2014-11-21
Z-2408-2015	Class II	Bronchial Double Lumen Tube Set (Right), Sterile	Teleflex Medical	BTS	2014-11-21
Z-2407-2015	Class II	Bronchial Double Lumen Tube Set (Left), Sterile	Teleflex Medical	BTS	2014-11-21
Z-1033-2015	Class II	DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C...	Express Diagnostics Int'l., Inc.	MGX	2014-11-21
Z-1747-2015	Class II	BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample...	Becton Dickinson & Co	N/A	2014-11-21
Z-1746-2015	Class II	BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A...	Becton Dickinson & Co	N/A	2014-11-21
Z-0832-2015	Class II	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high...	Instrumentation Laboratory Co.	GJS	2014-11-21
Z-0507-2015	Class II	TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1...	Accuray Incorporated	IYE	2014-11-21
Z-0824-2015	Class II	Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni...	Zimmer Manufacturing B.V.	LPH	2014-11-21
Z-0899-2015	Class II	Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe...	Abbott Medical	FMI	2014-11-21
Z-0898-2015	Class II	Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe...	Abbott Medical	FMI	2014-11-21
Z-0897-2015	Class II	Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product...	Abbott Medical	FMI	2014-11-21
Z-0835-2015	Class II	Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging...	Intuitive Surgical, Inc.	GCJ	2014-11-21
Z-0834-2015	Class II	Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging...	Intuitive Surgical, Inc.	GCJ	2014-11-21
Z-0895-2015	Class II	Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek...	AtriCure, Inc.	GEH	2014-11-21
Z-0947-2015	Class II	Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All...	Phadia AB	DHB	2014-11-20
Z-0855-2015	Class II	UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for...	Unistrip Technologies LLC	NBW	2014-11-20
Z-0858-2015	Class II	Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System...	LivaNova USA, Inc.	LYJ	2014-11-20
Z-0894-2015	Class II	ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0893-2015	Class II	ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0892-2015	Class II	ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0891-2015	Class II	ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0890-2015	Class II	ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0889-2015	Class II	ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0888-2015	Class II	ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0887-2015	Class II	ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0886-2015	Class II	ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0885-2015	Class II	ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0884-2015	Class II	ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0883-2015	Class II	ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion...	Roche Diagnostics GmbH	FPA	2014-11-20
Z-0580-2015	Class II	IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog...	Boston Scientific Corporation	DRF	2014-11-20
Z-1307-2015	Class II	Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to...	Philips North America LLC	LNH	2014-11-20
Z-0273-2016	Class II	ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for...	Philips North America LLC	MKJ	2014-11-19
Z-0957-2015	Class II	iPlan RT is a radiation treatment planning system that is intended for use in...	Brainlab, Inc.	MUJ	2014-11-19