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 678 of 1191

FDA device recalls, page 678 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0567-2015	Class II	Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal...	PFM Medical GmbH	GCB	2014-10-20
Z-0566-2015	Class II	Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short...	PFM Medical GmbH	GCB	2014-10-20
Z-0501-2015	Class II	MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the...	Microgenics Corporation	JJY	2014-10-20
Z-0565-2015	Class II	ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical...	PFM Medical GmbH	LJS	2014-10-20
Z-0564-2015	Class II	6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter...	PFM Medical GmbH	LJS	2014-10-20
Z-0563-2015	Class II	Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These...	PFM Medical GmbH	LJS	2014-10-20
Z-0562-2015	Class II	ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit...	PFM Medical GmbH	DWM	2014-10-20
Z-0561-2015	Class II	ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001...	PFM Medical GmbH	DWM	2014-10-20
Z-0560-2015	Class II	Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term...	PFM Medical GmbH	GCB	2014-10-20
Z-0873-2015	Class II	HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for...	Radiometer America, Inc	CGA	2014-10-20
Z-0212-2015	Class III	IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000...	Siemens Healthcare Diagnostics Inc.	JJY	2014-10-20
Z-0139-2015	Class II	ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703...	Biosense Webster Inc	LPB	2014-10-19
Z-2687-2017	Class II	Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006...	Mallinckrodt Manufacturing LLC	NBE	2014-10-17
Z-0522-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0521-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0492-2015	Class II	Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made...	Ethicon, Inc	GAP	2014-10-17
Z-0520-2015	Class II	Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0519-2015	Class II	Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0518-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0517-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0516-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0515-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0514-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0513-2015	Class II	Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0512-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI...	Biomet Microfixation	LZD	2014-10-17
Z-0511-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction...	Biomet Microfixation	LZD	2014-10-17
Z-0510-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti...	Biomet Microfixation	LZD	2014-10-17
Z-0509-2015	Class II	Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand	Biomet Microfixation	LZD	2014-10-17
Z-0575-2015	Class II	INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers...	Mallinckrodt Manufacturing LLC	MRN	2014-10-17
Z-0211-2015	Class II	Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal...	Maquet Cardiovascular Us Sales, LLC	DTQ	2014-10-17
Z-0171-2015	Class I	Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number...	Siemens Healthcare Diagnostics Inc.	LON	2014-10-17
Z-0170-2015	Class I	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are...	Siemens Healthcare Diagnostics Inc.	LON	2014-10-17
Z-1009-2015	Class II	The Synthes Mandible External Fixator; all lots of part nos...	Synthes GmbH	MQN	2014-10-17
Z-0200-2015	Class II	Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A...	Remel Inc	JSK	2014-10-17
Z-0418-2015	Class II	Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to...	Materialise USA, LLC.	JWH	2014-10-16
Z-0582-2015	Class II	Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for...	Skeletal Dynamics, Inc	KWI	2014-10-16
Z-0234-2015	Class III	Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a...	bioMerieux, Inc.	JWY	2014-10-16
Z-0233-2015	Class III	Etest Ceftaroline (CPT32) US B100. Etest (Antimicrobial Susceptibility Testing) is a...	bioMerieux, Inc.	JWY	2014-10-16
Z-0232-2015	Class III	Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a...	bioMerieux, Inc.	JWY	2014-10-16
Z-0231-2015	Class III	Etest Ceftaroline (CPT32) WWB100. Etest (Antimicrobial Susceptibility Testing) is a...	bioMerieux, Inc.	JWY	2014-10-16
Z-0230-2015	Class III	Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a...	bioMerieux, Inc.	JWY	2014-10-16
Z-0417-2015	Class II	MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to...	Ortho-Clinical Diagnostics, Inc.	JZH	2014-10-16
Z-0806-2015	Class II	AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF...	American Medical Systems, Inc.	OTM	2014-10-15
Z-0805-2015	Class II	AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C...	American Medical Systems, Inc.	OTN	2014-10-15
Z-0464-2015	Class II	AlignRT- Intended for prescription use. The system is indicated for use during...	Vision Rt Inc	IYE	2014-10-15
Z-0199-2015	Class II	ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap...	Depuy Orthopaedics Inc.	LXH	2014-10-15
Z-0189-2015	Class II	Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models...	GE Healthcare	KPS	2014-10-14
Z-0188-2015	Class II	Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640...	GE Healthcare	KPS	2014-10-14
Z-0187-2015	Class II	Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models...	GE Healthcare	KPS	2014-10-14
Z-0186-2015	Class II	Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system...	GE Healthcare	KPS	2014-10-14