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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 800 of 1190

FDA device recalls, page 800 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0753-2014	Class II	MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for...	The Anspach Effort, Inc.	HBE	2012-03-29
Z-0752-2014	Class II	MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for...	The Anspach Effort, Inc.	HBE	2012-03-29
Z-0751-2014	Class II	MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for...	The Anspach Effort, Inc.	HBE	2012-03-29
Z-0750-2014	Class II	MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for...	The Anspach Effort, Inc.	HBE	2012-03-29
Z-0749-2014	Class II	Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in...	The Anspach Effort, Inc.	HBE	2012-03-29
Z-1827-2012	Class I	Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2012-03-29
Z-1826-2012	Class I	Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2012-03-29
Z-1479-2012		Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P...	Smith & Nephew, Inc.	GCJ	2012-03-29
Z-1546-2012		RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro...	Theratest Laboratories, Inc.	DHR	2012-03-29
Z-0617-2013	Class III	Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO...	Abbott Medical	DYB	2012-03-28
Z-0894-2013	Class II	Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or...	Abbott Medical	MHY	2012-03-28
Z-1463-2012		GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and...	Abbott Medical	FRN	2012-03-28
Z-1127-2015	Class II	MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation...	Nidek Incorporated	HQF	2012-03-27
Z-2241-2013	Class II	GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.	GE Healthcare	LLZ	2012-03-27
Z-1774-2013	Class II	PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.	Iridex Corporation	HQF	2012-03-27
Z-0662-2013	Class II	CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and...	Maquet Cardiovascular LLC	DSP	2012-03-27
Z-2138-2012	Class II	TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens...	Tango3, LLC	FIN	2012-03-26
Z-1693-2012		Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning...	Philips North America LLC	JAK	2012-03-26
Z-1692-2012		Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is...	Philips North America LLC	JAK	2012-03-26
Z-1691-2012		Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model...	Philips North America LLC	JAK	2012-03-26
Z-1690-2012		Brilliance 16 - Model #728246, CT Scanning System is subject to...	Philips North America LLC	JAK	2012-03-26
Z-1364-2012		Siemens MAGNETOM Verio Use: Nuclear resonance imaging system	Siemens Medical Solutions USA, Inc.	LNH	2012-03-26
Z-0623-2013	Class II	Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole...	B Braun Medical Inc	FRN	2012-03-23
Z-2158-2012	Class II	*REF IFNT611Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm**Sterile by...	ZimVie US Corp LLC	NHA	2012-03-23
Z-1992-2012	Class I	Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed...	B Braun Medical Inc	FRN	2012-03-23
Z-1874-2012	Class II	Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC...	Colgate-Palmolive Company	MMD	2012-03-23
Z-1873-2012	Class II	Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist...	Colgate-Palmolive Company	MMD	2012-03-23
Z-1872-2012	Class II	Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist...	Colgate-Palmolive Company	MMD	2012-03-23
Z-1871-2012	Class II	Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist...	Colgate-Palmolive Company	MMD	2012-03-23
Z-1522-2012		The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading...	STERIS Corporation	FLE	2012-03-23
Z-1544-2012		PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE...	Materialise USA, LLC.	JWH	2012-03-23
Z-1543-2012		PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE...	Materialise USA, LLC.	JWH	2012-03-23
Z-1870-2012	Class II	Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive...	Colgate-Palmolive Company	MMD	2012-03-23
Z-0752-2013	Class II	Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw...	Extremity Medical, LLC	HWC	2012-03-22
Z-1545-2012		Instructions For Use: "*SmartLOX*Instructions for Use Cervical Plate...	CAPTIVA SPINE, Inc.	KWQ	2012-03-22
Z-1815-2012	Class III	PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the...	Becton Dickinson & Co	MKQ	2012-03-22
Z-1814-2012	Class III	Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529	Becton Dickinson & Co	MKQ	2012-03-22
Z-1813-2012	Class III	PrepStain Installation Kit (PreCoat), Catalog/Model # 490528	Becton Dickinson & Co	MKQ	2012-03-22
Z-1812-2012	Class III	PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523	Becton Dickinson & Co	MKQ	2012-03-22
Z-1811-2012	Class III	PrepStain Syringing Pipettes 240 (Catalog #490517)	Becton Dickinson & Co	MKQ	2012-03-22
Z-1515-2012		Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx...	Zimmer GmbH	DZE	2012-03-22
Z-1514-2012		Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX...	Zimmer GmbH	DZE	2012-03-22
Z-1513-2012		Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R...	Zimmer GmbH	DZE	2012-03-22
Z-1512-2012		Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R...	Zimmer GmbH	DZE	2012-03-22
Z-1511-2012		Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R...	Zimmer GmbH	DZE	2012-03-22
Z-1510-2012		Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R...	Zimmer GmbH	DZE	2012-03-22
Z-1453-2012		Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-21
Z-1452-2012		Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-21
Z-1451-2012		Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-21
Z-1450-2012		Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-21