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 787 of 1190

FDA device recalls, page 787 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2161-2012	Class II	Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental...	Straumann USA, LLC	NHA	2012-07-11
Z-2244-2012	Class II	Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R...	Medtronic Navigation, Inc	OXO	2012-07-11
Z-2208-2012	Class II	Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643...	Philips North America LLC	IXR	2012-07-11
Z-2156-2012	Class II	Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product...	Philips North America LLC	KPR	2012-07-11
Z-0032-2013	Class II	Caremor Cliner is labeled in part: "*Manufactured By Winco*Ocala, FL 34474...	Champion Mfg, Inc.	INM	2012-07-10
Z-0031-2013	Class II	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.com**Model No...	Champion Mfg, Inc.	INM	2012-07-10
Z-2256-2012	Class II	Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.	GE Healthcare	IZL	2012-07-10
Z-2255-2012	Class II	Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.	GE Healthcare	IZL	2012-07-10
Z-2148-2012	Class III	Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of...	Berchtold Corp.	FWH	2012-07-10
Z-2069-2012	Class II	IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates...	AGFA Healthcare Corp.	LLZ	2012-07-10
Z-2199-2012	Class II	SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for...	Sentec AG	LKD	2012-07-09
Z-2149-2012	Class II	Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange...	Apheresis Technologies, Inc.	FIR	2012-07-09
Z-2124-2012	Class III	IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number...	International Remote Imaging Systems	JJW	2012-07-09
Z-2112-2012	Class II	Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital...	Beekley Corporation	JAC	2012-07-09
Z-2111-2012	Class II	Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin...	Beekley Corporation	JAC	2012-07-09
Z-2110-2012	Class II	Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin...	Beekley Corporation	JAC	2012-07-09
Z-2109-2012	Class II	Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin...	Beekley Corporation	JAC	2012-07-09
Z-0059-2013	Class II	Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC...	Siemens Healthcare Diagnostics Inc.	JJE	2012-07-06
Z-2151-2012	Class II	PopLok Punch labeled in part: "PKL-35M*3.5mmQTY 1PopLok Punch*ConMed Linvatec...	Linvatec Corporation	LXH	2012-07-06
Z-2150-2012	Class II	Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously...	Finapres Medical Systems B.V.	DXN	2012-07-06
Z-2132-2012	Class II	Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container...	Baxter Healthcare Renal Div	FKX	2012-07-06
Z-0258-2013	Class II	MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile...	Kimberly-Clark Corporation	FYA	2012-07-05
Z-0257-2013	Class II	ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single...	Kimberly-Clark Corporation	KKX	2012-07-05
Z-0163-2013	Class II	Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1...	Howmedica Osteonics Corp	LXH	2012-07-05
Z-2164-2012	Class II	ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro...	Radiometer America, Inc	CHL	2012-07-05
Z-2163-2012	Class II	The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are...	Radiometer America, Inc	CHL	2012-07-05
Z-2206-2012	Class I	Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S...	Synthes GmbH	MTJ	2012-07-05
Z-2162-2012	Class II	The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the...	Radiometer America, Inc	CHL	2012-07-05
Z-1179-2013	Class II	Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray...	Chicago X-Ray Systems, Inc.	EAP	2012-07-03
Z-0266-2013	Class II	Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed...	Howmedica Osteonics Corp	KTT	2012-07-03
Z-2417-2012	Class II	Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone...	STERIS Corporation	MLR	2012-07-03
Z-2440-2012	Class II	BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the...	Opti Medical Systems Inc	CHL	2012-07-03
Z-2168-2012	Class II	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID...	Smith & Nephew, Inc.	MBI	2012-07-03
Z-2167-2012	Class II	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue...	Smith & Nephew, Inc.	MBI	2012-07-03
Z-2166-2012	Class II	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue)...	Smith & Nephew, Inc.	MBI	2012-07-03
Z-2165-2012	Class II	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures...	Smith & Nephew, Inc.	MBI	2012-07-03
Z-2341-2016	Class II	Merge HEMO software.	Merge Healthcare Incorporated	DQK	2012-07-02
Z-0111-2013	Class II	EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA...	Ethicon, Inc	FMF	2012-07-02
Z-2467-2012	Class II	KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ...	Kenvue Brands LLC	NUC	2012-07-02
Z-2154-2012	Class II	3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America...	Greiner Bio-One North America, Inc.	GIM	2012-07-02
Z-2137-2012	Class II	SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are...	Asensus Surgical, Inc.	GCJ	2012-07-02
Z-2153-2012	Class II	Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0...	Varian Medical Systems, Inc.	IYE	2012-07-02
Z-2035-2012	Class II	Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray...	Philips North America LLC	JAK	2012-07-02
Z-1950-2012	Class II	Drager PT 4000 Phototherapy System	Draeger Medical Systems, Inc.	LBI	2012-07-02
Z-2080-2012	Class II	Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product...	Beekley Corporation	IZH	2012-07-02
Z-2185-2012	Class I	Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended...	CareFusion 303, Inc	FRN	2012-06-29
Z-1642-2014	Class II	MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray...	FUJIFILM Healthcare Americas Corporation	MUE	2012-06-29
Z-2327-2012	Class II	Bard Foley procedural trays packaged in breather bags. The product is packaged ten units...	C.R. Bard Inc	EZC	2012-06-29
Z-2397-2012	Class II	BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup...	Becton, Dickinson and Company, BD Biosciences	GKZ	2012-06-29
Z-1949-2012	Class II	Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V...	Arjo, Inc.	FSA	2012-06-29