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 597 of 1191

FDA device recalls, page 597 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1284-2016	Class II	AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-1283-2016	Class II	AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-18
Z-1392-2016	Class II	Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage...	Synthes (USA) Products LLC	MAX	2016-02-18
Z-1587-2016	Class II	The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an...	Livongo Health, Inc.	NBW	2016-02-18
Z-1182-2016	Class II	McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and...	Change Healthcare Canada Company	LLZ	2016-02-18
Z-1700-2016	Class II	1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device...	Ortho-Clinical Diagnostics, Inc.	DHA	2016-02-18
Z-1090-2016	Class II	ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use...	TEM Systems Inc	GGN	2016-02-18
Z-2774-2016	Class II	Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2016-02-17
Z-2773-2016	Class II	Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2016-02-17
Z-2772-2016	Class II	Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2016-02-17
Z-2771-2016	Class II	Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2016-02-17
Z-2106-2016	Class II	Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while...	Medical Depot Inc.	INP	2016-02-17
Z-2105-2016	Class II	Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per...	Medical Depot Inc.	INP	2016-02-17
Z-2104-2016	Class II	Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per...	Medical Depot Inc.	INP	2016-02-17
Z-2103-2016	Class II	Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving...	Medical Depot Inc.	INP	2016-02-17
Z-2102-2016	Class II	EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch...	Medical Depot Inc.	INP	2016-02-17
Z-2101-2016	Class II	Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case...	Medical Depot Inc.	INP	2016-02-17
Z-1530-2016	Class II	Acorn 180 Curved Stairlift	Acorn Stairlifts, Inc	PCD	2016-02-17
Z-1382-2016	Class II	GE Healthcare, Aisys Carestation.	GE Healthcare	BSZ	2016-02-17
Z-1381-2016	Class II	GE Healthcare, Aisys CS2 anesthesia..	GE Healthcare	BSZ	2016-02-17
Z-1029-2016	Class II	ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast...	Argon Medical Devices, Inc	DRE	2016-02-17
Z-1611-2016	Class II	Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a...	Applied Medical Technology Inc	GAD	2016-02-17
Z-1610-2016	Class II	Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation...	Applied Medical Technology Inc	GAD	2016-02-17
Z-1609-2016	Class II	TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not...	Applied Medical Technology Inc	GAD	2016-02-17
Z-1608-2016	Class II	TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO...	Applied Medical Technology Inc	GAD	2016-02-17
Z-2158-2016	Class II	3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2157-2016	Class II	4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2156-2016	Class II	4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2155-2016	Class II	4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2154-2016	Class II	7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2153-2016	Class II	6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-2152-2016	Class II	6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation...	Synthes (USA) Products LLC	HWC	2016-02-16
Z-1312-2016	Class II	Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical...	Synthes (USA) Products LLC	FZX	2016-02-16
Z-1622-2016	Class II	Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in...	Siemens Healthcare Diagnostics Inc.	CDQ	2016-02-16
Z-1281-2016	Class II	CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-16
Z-1565-2016	Class II	Automated peritoneal dialysis (APD) cycler	Baxter Healthcare Corporation	FKX	2016-02-16
Z-1348-2016	Class II	VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 &...	Ortho-Clinical Diagnostics, Inc.	JJE	2016-02-16
Z-1319-2016	Class III	Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an...	Richard-Allan Scientific LLC	IDT	2016-02-16
Z-1054-2016	Class II	Milex Arcing Diaphragm Size 95; Model Number: MXWS95	CooperSurgical, Inc.	HDW	2016-02-16
Z-1191-2016	Class II	da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model...	Intuitive Surgical, Inc.	NAY	2016-02-16
Z-0885-2016	Class II	HipLOC CHS Plate/Lag Screw Introducer	Zimmer GmbH	LXH	2016-02-16
Z-1093-2016	Class II	Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet...	Zimmer GmbH	GAD	2016-02-16
Z-1307-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1306-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1305-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1304-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1303-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1302-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1301-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15
Z-1300-2016	Class II	Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to...	Siemens Medical Solutions USA, Inc.	JAK	2016-02-15