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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 493 of 1191

FDA device recalls, page 493 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0654-2018	Class II	Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-10-17
Z-0653-2018	Class II	Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-10-17
Z-0652-2018	Class II	Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-10-17
Z-0651-2018	Class II	Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-10-17
Z-0650-2018	Class II	Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-10-17
Z-0649-2018	Class II	Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-10-17
Z-0648-2018	Class II	Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-10-17
Z-0647-2018	Class II	Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-10-17
Z-0827-2018	Class II	BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC...	Siemens Healthcare Diagnostics Inc.	GJA	2017-10-17
Z-1288-2018	Class II	Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per...	Southmedic Inc.	CCK	2017-10-17
Z-0114-2018	Class II	3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360...	3M Company	FLL	2017-10-17
Z-1216-2018	Class II	The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control...	Stryker Corp.	HAW	2017-10-16
Z-1179-2018	Class III	STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K	Keystone Dental Inc.	DZE	2017-10-16
Z-0271-2018	Class II	Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains...	C.R. Bard Inc	DWJ	2017-10-16
Z-0199-2018	Class II	DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a)...	DeRoyal Industries, Inc.	LRO	2017-10-16
Z-0203-2018	Class II	Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the...	Fukuda Denshi Co., Ltd.	MHX	2017-10-16
Z-0235-2018	Class II	Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance...	Normand-Info S.A.S.U.	JQP	2017-10-16
Z-1007-2018	Class II	MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions...	Medtronic, Inc.	MPB	2017-10-14
Z-0966-2018	Class II	Femoral Artery Pressure Monitoring Set	Cook Incorporated	DQY	2017-10-13
Z-0965-2018	Class II	Left Atrial Catheter Set	Cook Incorporated	DQY	2017-10-13
Z-0964-2018	Class II	Central Venous Catheter Tray	Cook Incorporated	DQY	2017-10-13
Z-0963-2018	Class II	TFE Coated Curved Newton LLT	Cook Incorporated	DQX	2017-10-13
Z-0962-2018	Class II	Rosen Curved Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0961-2018	Class II	Reuter Tip Deflecting Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0960-2018	Class II	Newton Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0959-2018	Class II	Movable Core Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0958-2018	Class II	Fixed Core Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0957-2018	Class II	Fixed Core Bentson	Cook Incorporated	DQX	2017-10-13
Z-0956-2018	Class II	Double Flexible Tipped Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0955-2018	Class II	Disposable Reuter Tip Deflecting Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0954-2018	Class II	Coons Interventional Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0953-2018	Class II	Bentson Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0952-2018	Class II	Bentson Plus Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0951-2018	Class II	Bentson Cerebral Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0950-2018	Class II	Amplatz Ultra Stiff Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0949-2018	Class II	Amplatz Stiff Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0948-2018	Class II	Amplatz Extra Stiff Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0947-2018	Class II	Amplatz Extra Stiff Whisker Wire Guide	Cook Incorporated	DQX	2017-10-13
Z-0523-2018	Class II	Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel...	Microtek Medical LLC	FTA	2017-10-13
Z-1130-2018	Class II	Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium...	Medtronic, Inc.	GDY	2017-10-12
Z-1072-2018	Class II	TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation...	Zimmer GmbH	MBI	2017-10-11
Z-1071-2018	Class II	TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts...	Zimmer GmbH	MBI	2017-10-11
Z-0580-2018	Class II	Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2	GE Medical Systems China Co., Ltd.	BSZ	2017-10-11
Z-0579-2018	Class II	Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1	GE Medical Systems China Co., Ltd.	BSZ	2017-10-11
Z-0072-2018	Class I	Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit...	GE Healthcare	BSZ	2017-10-11
Z-0282-2018	Class II	Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit...	ZimVie US Corp LLC	NDP	2017-10-11
Z-0281-2018	Class II	Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit...	ZimVie US Corp LLC	NDP	2017-10-11
Z-0280-2018	Class II	Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The...	ZimVie US Corp LLC	NDP	2017-10-11
Z-0279-2018	Class II	Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by...	ZimVie US Corp LLC	NDP	2017-10-11
Z-0074-2018	Class II	Vitek2 Gp-Id, Ref 21342 IVD	bioMerieux, Inc.	LQL	2017-10-11