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 795 of 1190

FDA device recalls, page 795 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2491-2012	Class II	Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley...	Securitas Healthcare LLC	KMI	2012-05-04
Z-2490-2012	Class II	Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley...	Securitas Healthcare LLC	KMI	2012-05-04
Z-2489-2012	Class II	Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security...	Securitas Healthcare LLC	KMI	2012-05-04
Z-2488-2012	Class II	Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security...	Securitas Healthcare LLC	KMI	2012-05-04
Z-1683-2012		Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country...	Terumo BCT, Ltd	LKN	2012-05-04
Z-1830-2012	Class I	Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R)...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2012-05-03
Z-1689-2012		Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a...	Philips North America LLC	IZL	2012-05-02
Z-1782-2012	Class I	NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1781-2012	Class I	NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1780-2012	Class I	NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1779-2012	Class I	NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1778-2012	Class I	NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1777-2012	Class I	NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1776-2012	Class I	NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1775-2012	Class I	NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1774-2012	Class I	NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.	Nidek Medical Products Inc	CAW	2012-05-01
Z-1945-2012	Class II	Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo...	Atom Medical Corporation	FMZ	2012-05-01
Z-2367-2012	Class II	Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system	Siemens Medical Solutions USA, Inc.	IZL	2012-04-30
Z-2341-2012	Class II	Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system	Siemens Medical Solutions USA, Inc.	JAA	2012-04-30
Z-2090-2012	Class II	Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill...	Howmedica Osteonics Corp	MEH	2012-04-30
Z-2089-2012	Class II	ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker...	Howmedica Osteonics Corp	MEH	2012-04-30
Z-2092-2012	Class II	Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional...	Zimmer GmbH	MBH	2012-04-30
Z-2091-2012	Class II	Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF...	Zimmer GmbH	MBH	2012-04-30
Z-1701-2012		IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests)...	Siemens Healthcare Diagnostics Inc.	CFP	2012-04-30
Z-1700-2012		IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test...	Siemens Healthcare Diagnostics Inc.	CFP	2012-04-30
Z-1644-2012		XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create...	Elekta Limited	MUJ	2012-04-30
Z-0020-2013	Class I	Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614...	Accutron Inc	BSZ	2012-04-29
Z-0019-2013	Class I	CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation...	Accutron Inc	BSZ	2012-04-29
Z-0018-2013	Class I	Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596...	Accutron Inc	BSZ	2012-04-29
Z-0017-2013	Class I	Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter...	Accutron Inc	BSZ	2012-04-29
Z-1994-2014	Class II	Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical...	Intuitive Surgical, Inc.	NAY	2012-04-27
Z-2181-2012	Class II	Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient...	Kimberly-Clark Corporation	DWJ	2012-04-27
Z-2024-2012	Class I	Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems...	Respironics, Inc.	CBK	2012-04-27
Z-1794-2012	Class II	PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery...	Plasma Surgical Inc.	GEI	2012-04-27
Z-1786-2012		Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter...	CAPTIVA SPINE, Inc.	MAX	2012-04-27
Z-1785-2012		Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a...	CAPTIVA SPINE, Inc.	MAX	2012-04-27
Z-1784-2012		Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part...	CAPTIVA SPINE, Inc.	MAX	2012-04-27
Z-1783-2012		Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part...	CAPTIVA SPINE, Inc.	MAX	2012-04-27
Z-0516-2013	Class II	Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products	Motorola Inc	RFZ	2012-04-27
Z-1792-2012	Class II	Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive...	MicroAire Surgical Instruments, LLC	GCY	2012-04-26
Z-1699-2012		VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-04-26
Z-2235-2012	Class II	The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST...	Howmedica Osteonics Corp	MNI	2012-04-25
Z-1616-2012		ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions...	Siemens Medical Solutions USA, Inc.	IYN	2012-04-25
Z-1491-2012		LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per...	Abbott Medical	FRN	2012-04-25
Z-0120-2013	Class III	The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part...	Ormco/Sybronendo	EJF	2012-04-24
Z-1100-2013	Class II	GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It...	GE Healthcare	LNH	2012-04-23
Z-2403-2012	Class II	Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS...	Roche Molecular Systems Inc	OYT	2012-04-23
Z-2155-2012	Class II	LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I...	Howmedica Osteonics Corp	GAD	2012-04-23
Z-1685-2012		Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM...	Siemens Medical Solutions USA, Inc.	IYO	2012-04-23
Z-1684-2012		Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM...	Siemens Medical Solutions USA, Inc.	IYO	2012-04-23