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 573 of 1191

FDA device recalls, page 573 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0101-2017	Class II	cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical...	Roche Diagnostics GmbH	JQP	2016-07-15
Z-0100-2017	Class II	Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for...	Roche Diagnostics GmbH	JJE	2016-07-15
Z-0099-2017	Class II	URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a...	Roche Diagnostics GmbH	JIL	2016-07-15
Z-0098-2017	Class II	Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled...	Roche Diagnostics GmbH	JQP	2016-07-15
Z-0097-2017	Class II	cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical...	Roche Diagnostics GmbH	JJE	2016-07-15
Z-0096-2017	Class II	cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use...	Roche Diagnostics GmbH	JJE	2016-07-15
Z-0095-2017	Class II	cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas...	Roche Diagnostics GmbH	JJE	2016-07-15
Z-0094-2017	Class II	Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry...	Roche Diagnostics GmbH	JJE	2016-07-15
Z-2750-2016	Class II	Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and...	Hill-Rom Inc.	KNC	2016-07-15
Z-2405-2016	Class II	Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can...	Iridex Corporation	HQF	2016-07-15
Z-0296-2017	Class II	Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex...	Ethicon Endo-Surgery Inc	GDW	2016-07-15
Z-0295-2017	Class II	Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex...	Ethicon Endo-Surgery Inc	GDW	2016-07-15
Z-2293-2016	Class II	MOSAIQ Oncology Information System	Elekta Limited	IYE	2016-07-15
Z-2836-2018	Class II	Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of...	DRG Instruments GmbH	PEJ	2016-07-14
Z-1797-2018	Class II	MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline...	Ortho-Clinical Diagnostics, Inc.	CIN	2016-07-14
Z-0614-2017	Class II	Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8...	Merge Healthcare Incorporated	LLZ	2016-07-14
Z-2677-2016	Class II	CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-2676-2016	Class II	STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-2675-2016	Class II	STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-2535-2016	Class II	Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512	Straumann USA, LLC	DZE	2016-07-14
Z-2534-2016	Class II	Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510	Straumann USA, LLC	DZE	2016-07-14
Z-2352-2016	Class II	VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No...	Ortho-Clinical Diagnostics, Inc.	CHP	2016-07-14
Z-2744-2016	Class II	Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek...	Microtek Medical LLC	KKX	2016-07-14
Z-2350-2016	Class II	CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-2349-2016	Class II	STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-2348-2016	Class II	STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical...	Intuitive Surgical, Inc.	NAY	2016-07-14
Z-0645-2017	Class II	LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay...	Diasorin Inc.	CHP	2016-07-13
Z-2626-2016	Class II	SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed...	Siemens Medical Solutions USA, Inc.	JAK	2016-07-13
Z-2625-2016	Class II	SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed...	Siemens Medical Solutions USA, Inc.	JAK	2016-07-13
Z-2624-2016	Class II	SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed...	Siemens Medical Solutions USA, Inc.	JAK	2016-07-13
Z-2395-2016	Class II	ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray...	Siemens Medical Solutions USA, Inc.	IZI	2016-07-13
Z-2394-2016	Class II	ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis...	Siemens Medical Solutions USA, Inc.	IZI	2016-07-13
Z-2393-2016	Class II	AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis...	Siemens Medical Solutions USA, Inc.	IZI	2016-07-13
Z-2329-2016	Class II	6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F...	Cordis US Corp.	MGB	2016-07-13
Z-2764-2019	Class III	Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech...	VitalScientific	JJE	2016-07-12
Z-2872-2016	Class II	McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture...	Change Healthcare Canada Company	LLZ	2016-07-12
Z-2550-2016	Class II	Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with...	ResMed Corp	BZD	2016-07-12
Z-2366-2019	Class II	Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to...	Bausch & Lomb Incorporated	HNN	2016-07-11
Z-0967-2017	Class II	SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization...	C.R. Bard Inc	KNX	2016-07-11
Z-2782-2016	Class III	Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96...	Trinity Biotech USA	PCL	2016-07-11
Z-0327-2017	Class II	Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose...	B Braun Medical Inc	LRP	2016-07-11
Z-2605-2016	Class II	Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use...	Agiliti Health - Corona	FNM	2016-07-11
Z-2831-2016	Class II	Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.	C.R. Bard Inc	EZL	2016-07-11
Z-2830-2016	Class II	Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.	C.R. Bard Inc	EZL	2016-07-11
Z-2365-2019	Class II	Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for...	Bausch & Lomb Incorporated	HNN	2016-07-11
Z-2362-2016	Class I	Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3...	Alere San Diego, Inc.	GJS	2016-07-11
Z-2361-2016	Class I	Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The...	Alere San Diego, Inc.	GJS	2016-07-11
Z-2360-2016	Class I	Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product...	Alere San Diego, Inc.	GJS	2016-07-11
Z-2359-2016	Class I	Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere...	Alere San Diego, Inc.	GJS	2016-07-11
Z-2358-2016	Class I	Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product...	Alere San Diego, Inc.	GJS	2016-07-11