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 777 of 1190

FDA device recalls, page 777 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0748-2013	Class I	GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation...	GE Healthcare	BTL	2012-10-15
Z-0468-2013	Class II	Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient...	Invivo Corporation	MWI	2012-10-15
Z-1816-2013	Class II	Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007...	Synthes GmbH	KTT	2012-10-12
Z-1821-2013	Class II	Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for...	Synthes GmbH	LXH	2012-10-12
Z-0799-2013	Class II	Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2012-10-12
Z-0764-2013	Class II	Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to...	Zevex, Inc.	LZH	2012-10-12
Z-0121-2013	Class II	GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for...	GE Healthcare	KPS	2012-10-12
Z-0566-2013	Class II	The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to...	Stryker Medical	FPO	2012-10-11
Z-0614-2013	Class II	COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample...	Roche Molecular Systems Inc	JJH	2012-10-11
Z-1867-2014	Class II	Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to...	Siemens Healthcare Diagnostics Inc.	JJE	2012-10-11
Z-0743-2013	Class II	Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic...	Alfa Wassermann	CEO	2012-10-10
Z-0633-2013	Class II	PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated...	Horiba Instruments Incorporated	JJE	2012-10-10
Z-0632-2013	Class II	ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic...	Horiba Instruments Incorporated	CIT	2012-10-10
Z-0801-2013	Class II	The product is a lyophilized growth supplement for use with dehydrated culture media to...	Remel Inc	JSK	2012-10-10
Z-0515-2013	Class II	MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted...	Siemens Medical Solutions USA, Inc.	FSY	2012-10-10
Z-0480-2013	Class II	Siemens Mobilette Mira, intended use as Mobile x-ray system.	Siemens Medical Solutions USA, Inc.	IZL	2012-10-10
Z-0988-2013	Class III	Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in...	Siemens Healthcare Diagnostics Inc.	JIT	2012-10-10
Z-1055-2017	Class II	Digital RID Plate Reader and Software Product Code: AD400	The Binding Site Group Ltd.	JZQ	2012-10-09
Z-0130-2015	Class II	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA...	Siemens Healthcare Diagnostics Inc.	DBF	2012-10-09
Z-0129-2015	Class II	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA...	Siemens Healthcare Diagnostics Inc.	DBF	2012-10-09
Z-0128-2015	Class II	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the...	Siemens Healthcare Diagnostics Inc.	DBF	2012-10-09
Z-2303-2013	Class II	Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in...	Radiometer America, Inc	KHP	2012-10-08
Z-0452-2013	Class II	Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro...	Siemens Healthcare Diagnostics Inc.	JIY	2012-10-08
Z-1869-2013	Class II	Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy...	SPINEFRONTIER, Inc. dba LESspine Innovations	FSM	2012-10-05
Z-1105-2013	Class II	Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3...	Siemens Medical Solutions USA, Inc.	LLZ	2012-10-05
Z-0196-2013	Class II	The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor...	GE Healthcare	MHX	2012-10-05
Z-0206-2013	Class II	Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc...	Philips North America LLC	IYE	2012-10-05
Z-0918-2013	Class II	PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure...	Ethicon Endo-Surgery Inc	GAG	2012-10-04
Z-0879-2013	Class II	BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga...	Baylis Medical Co., Inc.	GXI	2012-10-04
Z-0415-2013	Class II	Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic...	Zimmer GmbH	KWA	2012-10-04
Z-0520-2013	Class II	STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with...	Advanced Sterilization Products	FRC	2012-10-03
Z-0182-2013	Class III	West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641...	DiaSorin Molecular LLC	NOP	2012-10-03
Z-0156-2013	Class II	Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution...	Baxter Corporation Englewood	NEP	2012-10-03
Z-0034-2014	Class II	Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication...	GE Healthcare	LLZ	2012-10-02
Z-0564-2013	Class II	Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ...	Becton Dickinson & Co	FMF	2012-10-02
Z-0536-2013	Class II	Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178	Ebi, LLC	HXX	2012-09-29
Z-0906-2013	Class II	Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray...	Philips North America LLC	JAK	2012-09-28
Z-0834-2013	Class II	VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use...	Ventana Medical Systems Inc	KPA	2012-09-28
Z-0833-2013	Class II	VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use...	Ventana Medical Systems Inc	KPA	2012-09-28
Z-0837-2013	Class II	Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and...	Accriva Diagnostics, Inc.	GJS	2012-09-28
Z-0607-2013	Class II	Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube...	Varian Medical Systems, Inc.	JAQ	2012-09-28
Z-0298-2013	Class II	Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The...	ZimVie US Corp LLC	DZE	2012-09-28
Z-0297-2013	Class II	Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x...	ZimVie US Corp LLC	DZE	2012-09-28
Z-0479-2013	Class II	Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260...	Philips North America LLC	KPS	2012-09-28
Z-0277-2013	Class II	Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for...	Synthes GmbH	KTT	2012-09-28
Z-0055-2013	Class II	3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS...	Abbott Medical	DQO	2012-09-28
Z-0139-2013	Class II	6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell...	Encore Medical, LP	HWC	2012-09-28
Z-0889-2013	Class II	Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413...	Cellestis Inc	NCD	2012-09-27
Z-0888-2013	Class II	VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50...	Cellestis Inc	NCD	2012-09-27
Z-1020-2013	Class II	DeGotzen XRay unit XGenus Dental X-ray unit.	De Gotzen S.r.l.	EAP	2012-09-26