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 692 of 1191

FDA device recalls, page 692 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2667-2014	Class II	Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The...	Genesisbps LLC	BRZ	2014-07-17
Z-2144-2014	Class II	Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant...	Zimmer GmbH	DZE	2014-07-17
Z-2235-2014	Class II	Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other...	Medtronic, Inc.	MWI	2014-07-17
Z-2234-2014	Class II	Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically...	Medtronic, Inc.	MWI	2014-07-17
Z-2290-2014	Class II	PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve	PENTAX of America, Inc.	KOG	2014-07-17
Z-2240-2014	Class II	TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software...	Accuray Incorporated	IYE	2014-07-16
Z-2183-2014	Class II	VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS...	Ortho-Clinical Diagnostics, Inc.	NIG	2014-07-16
Z-2553-2014	Class II	Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to...	Siemens Healthcare Diagnostics Inc.	JJE	2014-07-16
Z-2178-2014	Class III	Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+...	AGFA Healthcare Corp.	IWZ	2014-07-16
Z-2129-2014	Class II	Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to...	Novocol, Inc.	KLE	2014-07-16
Z-2128-2014	Class II	Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL...	Novocol, Inc.	KLE	2014-07-16
Z-2145-2014	Class II	Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic...	MARKET-TIERS, Inc. d/b/a Blue Endo	HET	2014-07-16
Z-2266-2014	Class II	Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company	Vascutek, Ltd.	DSY	2014-07-15
Z-2238-2014	Class II	Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system...	Siemens Healthcare Diagnostics Inc.	JMG	2014-07-15
Z-2214-2014	Class II	VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169...	Ortho-Clinical Diagnostics, Inc.	JIX	2014-07-15
Z-2609-2014	Class II	AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic...	AB Sciex, LLC	DOP	2014-07-15
Z-2259-2014	Class II	Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use...	Medtronic Neuromodulation	MHY	2014-07-14
Z-2615-2014	Class II	*BaxterNon-DEHPBURETROL Solution Set 105" (2.7 m), 150 mL Burette*Drip Chamber...	Baxter Healthcare Corporation	FPA	2014-07-14
Z-2614-2014	Class II	*BaxterBURETROL Solution Set105" (2.7 m) 150 mL Burette*Drip Chamber Filter...	Baxter Healthcare Corporation	FPA	2014-07-14
Z-2613-2014	Class II	*BaxterBuretrol Solution Set105" (2.7 m)150 mL Burette**Drip Chamber Filter...	Baxter Healthcare Corporation	FPA	2014-07-14
Z-2641-2014	Class II	Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each...	Amerx Health Care Corp.	MGQ	2014-07-11
Z-2640-2014	Class II	Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound...	Amerx Health Care Corp.	MGQ	2014-07-11
Z-2639-2014	Class II	Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply...	Amerx Health Care Corp.	MGQ	2014-07-11
Z-2638-2014	Class II	Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.	Amerx Health Care Corp.	MGQ	2014-07-11
Z-2257-2014	Class II	Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE...	Ortho Development Corp.	JWH	2014-07-11
Z-2256-2014	Class II	Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component...	Ortho Development Corp.	JWH	2014-07-11
Z-2255-2014	Class II	PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to...	Ortho Development Corp.	JWH	2014-07-11
Z-2254-2014	Class II	Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to...	Ortho Development Corp.	JWH	2014-07-11
Z-2253-2014	Class II	Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a...	Ortho Development Corp.	KWY	2014-07-11
Z-2136-2014	Class II	Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex...	Xtant Medical Holdings, Inc.	FZX	2014-07-11
Z-2172-2014	Class II	Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal...	Medtronic Neuromodulation	LKK	2014-07-11
Z-2181-2014	Class II	Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable...	Beevers Manufacturing & Supply, Inc.	PDH	2014-07-11
Z-2126-2014	Class II	FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used...	Baxter Healthcare Corporation	DPW	2014-07-11
Z-2585-2014	Class II	Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number...	Zimmer GmbH	JWH	2014-07-10
Z-2584-2014	Class II	Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number...	Zimmer GmbH	JWH	2014-07-10
Z-2583-2014	Class II	Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number...	Zimmer GmbH	JWH	2014-07-10
Z-2582-2014	Class II	Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number...	Zimmer GmbH	JWH	2014-07-10
Z-2211-2014	Class II	Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #...	Medical Positioning Inc	LGX	2014-07-10
Z-2210-2014	Class II	Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered...	Medical Positioning Inc	LGX	2014-07-10
Z-2209-2014	Class II	Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #...	Medical Positioning Inc	LGX	2014-07-10
Z-2208-2014	Class II	Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #...	Medical Positioning Inc	LGX	2014-07-10
Z-2154-2014	Class III	RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx...	Teleflex Medical	FCM	2014-07-10
Z-2236-2014	Class II	Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test...	Luminex Corporation	PEN	2014-07-09
Z-0037-2015	Class II	The Hulka Clip is a sterile packaged medical device that carries a two year expiration...	Richard Wolf Medical Instruments Corp.	KNH	2014-07-09
Z-2119-2014	Class II	Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a...	Teleflex Medical	CCW	2014-07-09
Z-2110-2014	Class II	QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software...	Philips North America LLC	LLZ	2014-07-09
Z-2109-2014	Class II	QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software...	Philips North America LLC	LLZ	2014-07-09
Z-2072-2014	Class II	Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's...	Integra LifeSciences Corporation	GWN	2014-07-09
Z-2108-2014	Class II	Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx...	Teleflex Medical	CAI	2014-07-09
Z-2107-2014	Class II	Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas...	Teleflex Medical	BTT	2014-07-09