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 782 of 1190

FDA device recalls, page 782 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0037-2013	Class II	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1...	Medtronic Sofamor Danek USA Inc	KWQ	2012-08-30
Z-0036-2013	Class II	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY...	Medtronic Sofamor Danek USA Inc	KWQ	2012-08-30
Z-2400-2012	Class II	Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model...	Vascular Solutions LLC	DTL	2012-08-30
Z-1932-2013	Class II	T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are...	SPINEFRONTIER, Inc. dba LESspine Innovations	MDM	2012-08-29
Z-0028-2013	Class II	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington...	Remington Medical	KNW	2012-08-29
Z-0070-2013	Class I	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2012-08-29
Z-0069-2013	Class I	Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2012-08-29
Z-0412-2013	Class II	Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide...	SPINEFRONTIER, Inc. dba LESspine Innovations	KWP	2012-08-28
Z-0054-2013	Class II	TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is...	KARDIUM Inc.	HXS	2012-08-28
Z-2395-2012	Class II	Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for...	Abbott Medical	KPE	2012-08-28
Z-0023-2013	Class II	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham...	bioMerieux, Inc.	LXG	2012-08-28
Z-2431-2012	Class II	Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of...	Sekisui Diagnostics, LLC	GGP	2012-08-28
Z-2404-2012	Class III	The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed...	Philips North America LLC	JAK	2012-08-28
Z-0386-2013	Class II	Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the...	Zimmer GmbH	KWZ	2012-08-27
Z-2382-2012	Class II	Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound...	GE Healthcare	DSI	2012-08-27
Z-0446-2013	Class II	The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set...	Iradimed Corporation	FRN	2012-08-24
Z-2345-2012	Class II	Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or...	Volcano Corporation	IYO	2012-08-24
Z-2386-2012	Class II	MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner...	Philips North America LLC	JAK	2012-08-24
Z-0932-2013	Class II	Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use...	Spine Smith Partners L.P.	MAX	2012-08-24
Z-2272-2013	Class I	Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit...	King Systems Corporation.	CAI	2012-08-23
Z-2486-2012	Class II	Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating...	Zimmer GmbH	HXX	2012-08-23
Z-2485-2012	Class II	Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating...	Zimmer GmbH	HXX	2012-08-23
Z-1025-2013	Class III	Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper...	Viscot Medical LLC	FZZ	2012-08-22
Z-2427-2012	Class II	12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS...	Smith & Nephew, Inc.	MEH	2012-08-22
Z-0417-2013	Class II	S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product...	SPINEFRONTIER, Inc. dba LESspine Innovations	MAX	2012-08-22
Z-2414-2012	Class II	S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil...	Depuy Orthopaedics Inc.	KWZ	2012-08-22
Z-0808-2013	Class II	Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50...	Remel Inc	JTN	2012-08-21
Z-0790-2013	Class II	Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid...	Remel Inc	JTN	2012-08-21
Z-0118-2013	Class II	Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze...	Elekta Limited	MUJ	2012-08-21
Z-0293-2013	Class I	ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ...	Ethicon, Inc	LMF	2012-08-21
Z-0673-2013	Class I	Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device*STERILE* Product...	Vycor Medical, Inc.	GZT	2012-08-21
Z-0292-2013	Class I	ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON...	Ethicon, Inc	LMF	2012-08-21
Z-2451-2012	Class II	Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp...	Philips North America LLC	JAK	2012-08-21
Z-2322-2012	Class II	Siemens Mobilett Mira. Mobile X-Ray System.	Siemens Medical Solutions USA, Inc.	IZL	2012-08-21
Z-2439-2012	Class II	Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2438-2012	Class II	Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2437-2012	Class II	Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2436-2012	Class II	Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2435-2012	Class II	Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2434-2012	Class II	Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2433-2012	Class II	Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-2432-2012	Class II	Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code...	Medtronic, Inc.	GDW	2012-08-21
Z-0807-2013	Class II	Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B...	Remel Inc	LLH	2012-08-20
Z-0806-2013	Class II	Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B...	Remel Inc	LLH	2012-08-20
Z-2450-2012	Class II	Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions...	Abbott Vascular	LIT	2012-08-20
Z-0379-2013	Class III	Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated...	Microgenics Corporation	JJY	2012-08-20
Z-0407-2013	Class II	Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core...	Vital Signs Colorado, Inc.	KAK	2012-08-17
Z-0388-2013	Class II	Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm...	Howmedica Osteonics Corp	HWC	2012-08-17
Z-0387-2013	Class II	Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm...	Howmedica Osteonics Corp	HWC	2012-08-17
Z-2462-2012	Class II	Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and...	Varian Medical Systems, Inc.	MUJ	2012-08-17