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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 728 of 1191

FDA device recalls, page 728 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0441-2014	Class II	Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF...	Boston Scientific Corporation	FED	2013-11-05
Z-0440-2014	Class II	Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF...	Boston Scientific Corporation	FED	2013-11-05
Z-0588-2014	Class II	Dist Lat Fem Lock Plt, Rt	Zimmer GmbH	HRS	2013-11-05
Z-0587-2014	Class II	Dist Lat Fem Lock Plt, Lt	Zimmer GmbH	FZS	2013-11-05
Z-0586-2014	Class II	Tibio Fem/fem Nail.	Zimmer GmbH	HSB	2013-11-05
Z-0585-2014	Class II	Fem Cond Buttress Plt, Rt.	Zimmer GmbH	HRS	2013-11-05
Z-0730-2014	Class II	Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl...	Zimmer GmbH	MBB	2013-11-04
Z-0512-2014	Class II	Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is...	Stryker Corp.	MJN	2013-11-04
Z-0511-2014	Class II	Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is...	Stryker Corp.	MJN	2013-11-04
Z-0510-2014	Class II	Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is...	Stryker Corp.	MJN	2013-11-04
Z-0509-2014	Class II	Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is...	Stryker Corp.	MJN	2013-11-04
Z-0508-2014	Class II	Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured...	Stryker Corp.	MJN	2013-11-04
Z-0507-2014	Class II	Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured...	Stryker Corp.	MJN	2013-11-04
Z-0506-2014	Class II	Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured...	Stryker Corp.	MJN	2013-11-04
Z-0505-2014	Class II	Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured...	Stryker Corp.	MJN	2013-11-04
Z-0504-2014	Class II	Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured...	Stryker Corp.	KRD	2013-11-04
Z-0503-2014	Class II	Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is...	Stryker Corp.	HCG	2013-11-04
Z-0502-2014	Class II	Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is...	Stryker Corp.	HCG	2013-11-04
Z-0501-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is...	Stryker Corp.	DQY	2013-11-04
Z-0500-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910; Product...	Stryker Corp.	DQY	2013-11-04
Z-0499-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product...	Stryker Corp.	DQY	2013-11-04
Z-0498-2014	Class II	Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is...	Stryker Corp.	DQY	2013-11-04
Z-0497-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is...	Stryker Corp.	DQY	2013-11-04
Z-0496-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is...	Stryker Corp.	DQY	2013-11-04
Z-0495-2014	Class II	Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is...	Stryker Corp.	DQY	2013-11-04
Z-0494-2014	Class II	Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is...	Stryker Corp.	DQY	2013-11-04
Z-0400-2014	Class II	LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver...	Highridge Medical, LLC	OVD	2013-11-04
Z-1612-2014	Class II	Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product...	MEDLINE INDUSTRIES, LP - Northfield	BYZ	2013-11-04
Z-0127-2014	Class II	Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable...	Stryker Corp.	HRX	2013-11-04
Z-0360-2014	Class II	Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in...	Salter Labs	CCK	2013-11-01
Z-0280-2014	Class II	Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer...	Stryker Corp.	JDZ	2013-11-01
Z-1483-2014	Class I	Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including...	Abbott Medical	FRN	2013-10-31
Z-1482-2014	Class I	Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole...	Abbott Medical	FRN	2013-10-31
Z-0480-2014	Class II	NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates...	Zimmer GmbH	JWH	2013-10-31
Z-0852-2014	Class II	The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates...	Acute Innovations, LLC	HRS	2013-10-30
Z-0466-2014	Class II	Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour...	Maquet Cardiovascular LLC	GEI	2013-10-30
Z-0431-2014	Class II	Easy Diagnost Eleva Universal Fluoroscopic applications	Philips North America LLC	KPR	2013-10-30
Z-0823-2014	Class II	Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink...	Siemens Healthcare Diagnostics Inc.	JQP	2013-10-30
Z-0371-2014	Class II	Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The...	Handicare USA, Inc.	FSA	2013-10-30
Z-0370-2014	Class II	Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The...	Handicare USA, Inc.	FSA	2013-10-30
Z-0850-2014	Class II	Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10...	Kimberly-Clark Corporation	GXI	2013-10-29
Z-0383-2014	Class III	MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)...	Thermofisher Scientive	JJW	2013-10-29
Z-1089-2014	Class II	Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and...	Orthofix SRL	KWQ	2013-10-29
Z-0533-2014	Class II	Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx...	Integra Pain Management	CAZ	2013-10-28
Z-0464-2014	Class II	Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural...	Centurion Medical Products, LP	LDQ	2013-10-28
Z-0116-2015	Class II	e.cam line of gamma camera systems Used to detect or image the distribution of...	Siemens Medical Solutions USA, Inc.	KPS	2013-10-28
Z-0115-2015	Class II	Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It...	Siemens Medical Solutions USA, Inc.	KPS	2013-10-28
Z-0339-2014	Class II	Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for...	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	GXQ	2013-10-28
Z-0338-2014	Class II	Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral...	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	DXZ	2013-10-28
Z-0451-2014	Class II	Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The...	Abbott Medical	GJS	2013-10-28