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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 751 of 1191

FDA device recalls, page 751 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1976-2013	Class I	Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5)...	Howmedica Osteonics Corp	KWP	2013-05-30
Z-1832-2013	Class II	Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes...	Exactech, Inc.	GFC	2013-05-30
Z-1692-2013	Class II	GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product...	DeRoyal Industries, Inc.	LRO	2013-05-30
Z-1612-2013	Class II	Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to...	Terumo Medical Corp.	DYB	2013-05-30
Z-1611-2013	Class II	Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut...	Terumo Medical Corp.	DYB	2013-05-30
Z-1681-2013	Class II	*REF C7122QTY 1**APEX Arthroscopy Tubing Set. Intended for use for joint...	Linvatec Corporation	HRX	2013-05-30
Z-1680-2013	Class II	*REF C7120*APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and...	Linvatec Corporation	HRX	2013-05-30
Z-1794-2013	Class II	TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress...	Hill-Rom Inc.	IOQ	2013-05-30
Z-1569-2013	Class II	Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module...	Terumo Cardiovascular Systems Corporation	DWC	2013-05-30
Z-0401-2014	Class II	Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD...	Synthes GmbH	JDP	2013-05-29
Z-1562-2013	Class II	ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the...	Siemens Medical Solutions USA, Inc.	IYE	2013-05-29
Z-1663-2013	Class II	Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac...	Siemens Medical Solutions USA, Inc.	IYE	2013-05-29
Z-1929-2013	Class II	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE...	Smith & Nephew, Inc.	MBL	2013-05-29
Z-1928-2013	Class II	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE...	Smith & Nephew, Inc.	MBL	2013-05-29
Z-1661-2013	Class II	VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a...	DJO, LLC	JOW	2013-05-28
Z-1065-2014	Class II	All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or...	Elekta Limited	IYE	2013-05-28
Z-1064-2014	Class II	SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy...	Elekta Limited	IYE	2013-05-28
Z-1533-2013	Class II	BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x...	Bard Peripheral Vascular Inc	DQY	2013-05-28
Z-1613-2013	Class II	SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when...	Siemens Healthcare Diagnostics Inc.	KHP	2013-05-28
Z-1744-2013	Class II	Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes...	Carl Zeiss Microscopy, LLC	IBJ	2013-05-28
Z-1671-2013	Class III	RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN)...	Boston Scientific Corporation	KNQ	2013-05-28
Z-1673-2013	Class II	NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog...	Boston Scientific Corporation	LJE	2013-05-28
Z-1672-2013	Class II	NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number...	Boston Scientific Corporation	LJE	2013-05-28
Z-1748-2013	Class II	Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number...	Boston Scientific Corporation	OOY	2013-05-28
Z-1595-2013	Class II	INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1594-2013	Class II	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1593-2013	Class II	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1592-2013	Class II	INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1591-2013	Class II	INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1590-2013	Class II	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1589-2013	Class II	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800...	Medtronic Sofamor Danek USA Inc	NEK	2013-05-28
Z-1541-2013	Class II	STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood...	Advanced Medical Optics, Inc.	LZS	2013-05-28
Z-1540-2013	Class II	STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing...	Advanced Medical Optics, Inc.	LZS	2013-05-28
Z-1539-2013	Class II	STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510...	Advanced Medical Optics, Inc.	LZS	2013-05-28
Z-1522-2013	Class II	StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental...	Dentalez, Inc., Stardental Division	NME	2013-05-28
Z-0222-2015	Class II	MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device...	Nidek Incorporated	HQF	2013-05-24
Z-1665-2013	Class II	S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional...	SPINEFRONTIER, Inc. dba LESspine Innovations	LXH	2013-05-24
Z-1531-2013	Class II	VIA Medical Collection Bag; The collection bag is an accessory waste bag used in...	International Biomedical, Ltd.	LZF	2013-05-24
Z-1523-2013	Class II	AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS...	Fenwal Inc	LKN	2013-05-24
Z-1439-2013	Class II	GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only...	Gyrus ACMI, Inc.	LRC	2013-05-24
Z-1693-2013	Class II	Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2013-05-24
Z-0177-2014	Class II	Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal...	Pinook USA	NGX	2013-05-23
Z-0176-2014	Class II	Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal...	Pinook USA	NGX	2013-05-23
Z-1818-2013	Class II	ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile...	Sotera Wireless	MWI	2013-05-23
Z-1817-2013	Class II	ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended...	Sotera Wireless	MWI	2013-05-23
Z-1621-2013	Class II	Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile...	Zimmer GmbH	LXH	2013-05-23
Z-1807-2013	Class II	Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower...	Etac Supply Center AB	INN	2013-05-23
Z-1504-2013	Class II	Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1503-2013	Class II	Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1502-2013	Class II	Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23