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 371 of 1190

FDA device recalls, page 371 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0430-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0429-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0428-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0427-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0426-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0425-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0424-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0423-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0422-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0421-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-1827-2020	Class II	CapsoCAM Plus, UDI: 00867770000209	CapsoVision, Inc.	NEZ	2019-10-18
Z-1229-2020	Class II	Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B...	Taewoong Medical Co., Ltd.	ESW	2019-10-18
Z-0655-2020	Class II	Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI...	Cp Medical	GAM	2019-10-18
Z-0591-2020	Class II	BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm...	Brasseler USA I, L.P.	GFF	2019-10-18
Z-0348-2020	Class II	Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)	Basic Reset Inc.	N/A	2019-10-18
Z-0405-2020	Class II	Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 370038694...	TORNIER Inc.	PHX	2019-10-18
Z-0761-2020	Class II	i-STAT cTnI cartridge	Abbott Medical	MMI	2019-10-16
Z-0271-2020	Class II	Hitachi Scenaria Whole-body X-ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	2019-10-16
Z-0602-2020	Class II	Quantam 2000 Electrosurgical Generator, Part number 909075-05W.	CooperSurgical, Inc.	HGI	2019-10-16
Z-0601-2020	Class II	Quantam 2000 Electrosurgical Generator, Part number 909075-05.	CooperSurgical, Inc.	HGI	2019-10-16
Z-0600-2020	Class II	Quantam 2000 Electrosurgical Generator, Part number 909075.	CooperSurgical, Inc.	HGI	2019-10-16
Z-0498-2020	Class II	HeartStart XL+ Defibrillator/Monitor, Model 861290	Philips North America LLC	MKJ	2019-10-16
Z-1934-2020	Class II	CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0	Cuattro Imaging, LLC	KPR	2019-10-15
Z-0091-2021	Class II	Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM...	Mizuho Orthopedic Systems Inc	JEA	2019-10-14
Z-0664-2020	Class II	Radiofrequency Grounding Pad, REF RF-DGP-L	Abbott Medical	GXD	2019-10-14
Z-0740-2020	Class II	Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine...	Ortho-Clinical Diagnostics, Inc.	KSG	2019-10-14
Z-0739-2020	Class II	7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute...	Ortho-Clinical Diagnostics, Inc.	DCF	2019-10-14
Z-0500-2020	Class II	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)	Becton Dickinson & Co	NGT	2019-10-14
Z-0499-2020	Class II	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547	Becton Dickinson & Co	NGT	2019-10-14
Z-2130-2020	Class II	Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The...	Teleflex Medical	BSP	2019-10-11
Z-2129-2020	Class II	Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The...	Teleflex Medical	BSP	2019-10-11
Z-1602-2020	Class II	Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000	STRYKER Communications, Inc.	FSY	2019-10-11
Z-1157-2020	Class II	Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x...	Implant Direct Sybron Manufacturing LLC	DZE	2019-10-11
Z-0862-2020	Class II	Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or...	Siemens Healthcare Diagnostics Inc.	JGS	2019-10-11
Z-0723-2020	Class II	ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The...	Lifelines Neuro Company	GWQ	2019-10-11
Z-0722-2020	Class II	ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The...	Lifelines Neuro Company	GWQ	2019-10-11
Z-0507-2020	Class II	The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric...	Nucryo Vascular Inc.	LIT	2019-10-11
Z-0541-2020	Class I	Giraffe Incubator infant warmer	GE Healthcare	FMT	2019-10-11
Z-0495-2020	Class II	MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042	AMD Medicom Inc.	FXX	2019-10-11
Z-0494-2020	Class II	MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040	AMD Medicom Inc.	FXX	2019-10-11
Z-0540-2020	Class I	Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer	GE Healthcare	FMT	2019-10-11
Z-0539-2020	Class I	Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed...	GE Healthcare	FMT	2019-10-11
Z-0538-2020	Class I	Giraffe OmniBed infant warmer	GE Healthcare	FMT	2019-10-11
Z-0508-2020	Class I	Synchromed II programmable pump, Model numbers 8637-20 and 8637-40	Medtronic Neuromodulation	LKK	2019-10-11
Z-2291-2020	Class II	4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection...	Biocare Medical LLC	NJT	2019-10-10
Z-1892-2020	Class II	3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI...	Trilliant Surgical LLC	HTW	2019-10-10
Z-2163-2020	Class II	Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S...	Hologic, Inc.	OCC	2019-10-10
Z-0338-2020	Class II	cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001	Zimmer GmbH	HTN	2019-10-10
Z-0337-2020	Class II	Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011...	Zimmer GmbH	HSB	2019-10-10
Z-0336-2020	Class II	Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 008775...	Zimmer GmbH	LZO	2019-10-10