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 761 of 1190

FDA device recalls, page 761 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1149-2013	Class II	MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product...	Maquet Cardiovascular LLC	DTQ	2013-03-07
Z-1177-2013	Class I	Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part...	Maquet Cardiovascular Us Sales, LLC	CBK	2013-03-07
Z-1156-2013	Class II	Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw...	Orthopedic Alliance, LLC	MNI	2013-03-07
Z-1809-2013	Class II	Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed...	Spinalight Inc	LXM	2013-03-06
Z-1619-2013	Class II	GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures...	Linvatec Corporation	MAI	2013-03-06
Z-1098-2013	Class I	Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit...	CareFusion 303, Inc	FRN	2013-03-06
Z-1178-2013	Class II	The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model...	Alere San Diego, Inc.	DCK	2013-03-06
Z-1272-2013	Class II	Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201...	Siemens Healthcare Diagnostics Inc.	LTT	2013-03-06
Z-0995-2013	Class II	KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)...	Kimberly-Clark Corporation	FRG	2013-03-06
Z-1139-2013	Class II	Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative...	Alere San Diego, Inc.	CKD	2013-03-06
Z-1132-2013	Class II	TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437...	Smith & Nephew, Inc.	HSB	2013-03-06
Z-1112-2013	Class II	Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit...	CareFusion 303, Inc	FRN	2013-03-06
Z-1114-2013	Class II	CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the...	Roche Diagnostics GmbH	GJS	2013-03-06
Z-1113-2013	Class II	ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the...	Roche Diagnostics GmbH	NBW	2013-03-06
Z-0571-2015	Class II	1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated...	Stryker Corp.	GCJ	2013-03-05
Z-0570-2015	Class II	1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera...	Stryker Corp.	GCJ	2013-03-05
Z-0569-2015	Class II	1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High...	Stryker Corp.	GCJ	2013-03-05
Z-1023-2013	Class II	20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended...	Biosense Webster Inc	DQK	2013-03-05
Z-1783-2014	Class II	Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX...	Philips North America LLC	MHX	2013-03-05
Z-1975-2013	Class II	Siemens syngo.plaza SW version VA20 with Mammography license. image processing...	Siemens Medical Solutions USA, Inc.	LLZ	2013-03-04
Z-1596-2013	Class II	Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH...	STERIS Corporation	MED	2013-03-04
Z-1166-2013	Class II	NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a...	Neusoft Medical Systems Co., Ltd.	JAK	2013-03-04
Z-1165-2013	Class II	NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz...	Neusoft Medical Systems Co., Ltd.	JAK	2013-03-04
Z-1420-2013	Class I	REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic...	Medtronic Xomed, Inc.	ETN	2013-03-04
Z-1057-2013	Class II	Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYG	2013-03-04
Z-1001-2013	Class III	Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage...	CareFusion 213 LLC	OJU	2013-03-04
Z-1280-2013	Class II	AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat...	American Medical Systems, Inc.	EZY	2013-03-01
Z-1279-2013	Class II	AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat...	American Medical Systems, Inc.	EZY	2013-03-01
Z-0965-2013	Class II	Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The...	Boston Scientific Corporation	LWS	2013-03-01
Z-1183-2013	Class II	Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter...	B Braun Medical Inc	FKQ	2013-03-01
Z-1028-2013	Class II	Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number...	Roche Diagnostics GmbH	OOI	2013-03-01
Z-1694-2013	Class II	Siemens Mammomat Inspiration - full-field digital mammography Product Usage...	Siemens Medical Solutions USA, Inc.	MUE	2013-02-28
Z-0959-2013	Class II	Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table...	Allen Medical Systems, Inc.	HST	2013-02-28
Z-1048-2013	Class III	Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-27
Z-1047-2013	Class III	Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-27
Z-1046-2013	Class III	Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-27
Z-0955-2013	Class I	Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in...	Vascular Solutions LLC	DTL	2013-02-27
Z-1162-2013	Class III	Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment...	Sirtex Medical Inc.	NAW	2013-02-27
Z-1031-2013	Class II	Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the...	Medtronic Neuromodulation	GEI	2013-02-27
Z-0946-2013	Class II	Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the...	Medtronic, Inc.	GWL	2013-02-27
Z-1518-2015	Class II	The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or...	Abbott Medical	MEA	2013-02-27
Z-1517-2015	Class II	The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia...	Abbott Medical	MEA	2013-02-27
Z-1734-2013	Class II	CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended...	Terumo Cardiovascular Systems Corporation	DRY	2013-02-27
Z-1733-2013	Class II	CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended...	Terumo Cardiovascular Systems Corporation	DRY	2013-02-27
Z-1732-2013	Class II	CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter...	Terumo Cardiovascular Systems Corporation	DRY	2013-02-27
Z-1731-2013	Class II	CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and...	Terumo Cardiovascular Systems Corporation	DRY	2013-02-27
Z-1730-2013	Class II	CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter...	Terumo Cardiovascular Systems Corporation	DRY	2013-02-27
Z-1247-2016	Class II	Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model...	Neurotherm, Inc.	GXI	2013-02-26
Z-1545-2014	Class III	CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.	Siemens Healthcare Diagnostics Inc.	KQO	2013-02-26
Z-1148-2013	Class III	IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog...	Alere San Diego, Inc.	KTN	2013-02-26