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 419 of 1190

FDA device recalls, page 419 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0846-2019	Class II	Pilling COOLEY SUMP-SUCTION TUBE, REF 351547	Teleflex Medical	JOL	2019-01-07
Z-1939-2020	Class II	SWIN 2017 database, Model YSW4000	Trek Diagnostic Systems, Ltd.	LON	2019-01-04
Z-1079-2019	Class II	iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111...	ConforMIS, Inc.	JWH	2019-01-04
Z-0978-2020	Class II	Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941...	Cook Incorporated	FAD	2019-01-04
Z-0977-2020	Class II	Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869...	Cook Incorporated	FAD	2019-01-04
Z-0976-2020	Class II	Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No...	Cook Incorporated	FAD	2019-01-04
Z-0975-2020	Class II	Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No...	Cook Incorporated	FAD	2019-01-04
Z-0974-2020	Class II	Kwart Retro-Inject Ureteral Stent Set, Global Product No...	Cook Incorporated	FAD	2019-01-04
Z-0973-2020	Class II	C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367	Cook Incorporated	FAD	2019-01-04
Z-0972-2020	Class II	Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823	Cook Incorporated	GBL	2019-01-04
Z-0971-2020	Class II	Urethral Dilator Set, Global Product No. G14185	Cook Incorporated	KOE	2019-01-04
Z-0970-2020	Class II	Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844	Cook Incorporated	KOE	2019-01-04
Z-0969-2020	Class II	Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329	Cook Incorporated	KOB	2019-01-04
Z-0968-2020	Class II	Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108	Cook Incorporated	KOB	2019-01-04
Z-0967-2020	Class II	Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649	Cook Incorporated	LJE	2019-01-04
Z-0966-2020	Class II	Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global...	Cook Incorporated	OCY	2019-01-04
Z-0965-2020	Class II	Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598	Cook Incorporated	OCY	2019-01-04
Z-0964-2020	Class II	Wire Guide, Guidewire, Global Product Number G14326	Cook Incorporated	OCY	2019-01-04
Z-0963-2020	Class II	Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866	Cook Incorporated	OCY	2019-01-04
Z-1681-2019	Class II	King LTS-D Kit Size 1, Model Number KLTSD431	King Systems Corporation.	CAE	2019-01-04
Z-0962-2020	Class II	PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10	Cook Incorporated	OCY	2019-01-04
Z-0961-2020	Class II	Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260	Cook Incorporated	OCY	2019-01-04
Z-0960-2020	Class II	Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285	Cook Incorporated	OCY	2019-01-04
Z-0959-2020	Class II	Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590	Cook Incorporated	OCY	2019-01-04
Z-1132-2019	Class II	Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for...	Wilson-Cook Medical Inc.	KNS	2019-01-04
Z-0706-2019	Class II	Elekta Unity	Elekta Limited	IYE	2019-01-04
Z-0805-2019	Class I	icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug...	Abbott Medical	ONB	2019-01-03
Z-0971-2019	Class II	ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the...	Abbott Medical	JGJ	2019-01-02
Z-0792-2019	Class III	BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD...	Becton, Dickinson and Company, BD Biosciences	OYE	2019-01-02
Z-0772-2019	Class II	Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical...	Leica Microsystems, Inc.	HRM	2019-01-02
Z-1101-2019	Class II	cone-beam CT system	KaVo Dental Technologies, LLC	OAS	2018-12-31
Z-0788-2019	Class II	GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model...	GE Healthcare	IYN	2018-12-28
Z-0758-2019	Class II	12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product...	Fetzer Medical GmbH & Co.KG	HDA	2018-12-28
Z-0757-2019	Class II	16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code...	Fetzer Medical GmbH & Co.KG	HDA	2018-12-28
Z-0756-2019	Class II	12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product...	Fetzer Medical GmbH & Co.KG	HDA	2018-12-28
Z-0755-2019	Class II	16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code...	Fetzer Medical GmbH & Co.KG	HDA	2018-12-28
Z-0957-2019	Class II	Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code...	Medtronic, Inc.	NAB	2018-12-27
Z-1013-2019	Class II	Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material...	Boston Scientific Corporation	FGE	2018-12-26
Z-1012-2019	Class II	Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material...	Boston Scientific Corporation	FGE	2018-12-26
Z-0824-2019	Class II	ATLAS Loading Car	STERIS Corporation	FLE	2018-12-26
Z-0769-2019	Class I	Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only	West Pharma. Services IL, Ltd.	LHI	2018-12-26
Z-0768-2019	Class I	Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only	West Pharma. Services IL, Ltd.	LHI	2018-12-26
Z-0771-2019	Class II	Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm...	Varian Medical Systems, Inc.	MUJ	2018-12-26
Z-0822-2019	Class III	Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive...	Luminex Corporation	PAM	2018-12-26
Z-0767-2019	Class I	Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only	West Pharma. Services IL, Ltd.	LHI	2018-12-26
Z-2498-2019	Class II	DigitalDiagnost C50, Stationary X-ray System	Philips North America LLC	KPR	2018-12-21
Z-0932-2019	Class II	Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System	Philips Medical Systems Nederland B.V.	LNH	2018-12-21
Z-0931-2019	Class II	Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System	Philips Medical Systems Nederland B.V.	LNH	2018-12-21
Z-0930-2019	Class II	MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System	Philips Medical Systems Nederland B.V.	LNH	2018-12-21
Z-0929-2019	Class II	NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging...	Philips Medical Systems Nederland B.V.	LNH	2018-12-21