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 775 of 1190

FDA device recalls, page 775 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0473-2013	Class II	Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas...	Roche Diagnostics GmbH	JJE	2012-11-01
Z-2164-2013	Class II	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used...	B Braun Medical Inc	FRN	2012-10-31
Z-0440-2013	Class II	Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The...	CooperSurgical, Inc.	LKF	2012-10-31
Z-0439-2013	Class II	Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended...	CooperSurgical, Inc.	LKF	2012-10-31
Z-1071-2013	Class II	Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a...	J. T. Posey Co.	FMQ	2012-10-31
Z-0872-2013	Class II	Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts...	Hill-Rom Inc.	FSA	2012-10-31
Z-0975-2013	Class II	Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill...	TORNIER Inc.	HTW	2012-10-30
Z-0900-2013	Class II	Philips Digital Diagnost Stationary radiographic system	Philips North America LLC	MQB	2012-10-30
Z-0475-2013	Class II	Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for...	Philips North America LLC	MQB	2012-10-30
Z-0740-2013	Class II	Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No...	Cordis US Corp.	MGB	2012-10-29
Z-0708-2014	Class II	Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters...	The Anspach Effort, Inc.	HBE	2012-10-26
Z-0483-2013	Class II	Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity...	Abbott Medical	FRN	2012-10-26
Z-0467-2013	Class II	BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an...	iwalk Inc	ISW	2012-10-26
Z-1873-2013	Class II	Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated...	Siemens Healthcare Diagnostics Inc.	JJE	2012-10-26
Z-0482-2013	Class II	Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a...	Abbott Medical	FRN	2012-10-26
Z-0481-2013	Class II	Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired...	Abbott Medical	FRN	2012-10-26
Z-0137-2015	Class II	Animas Vibe Insulin Infusion Pump and System. These products are indicated for...	Animas Corp.	LZG	2012-10-25
Z-0966-2013	Class III	20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during...	Volk Optical Inc	HJL	2012-10-25
Z-0695-2013	Class II	Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.	Howmedica Osteonics Corp	KTT	2012-10-25
Z-0884-2013	Class II	Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020...	Philips North America LLC	MQB	2012-10-25
Z-0478-2013	Class I	The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a...	Verathon Inc.	CCW	2012-10-25
Z-0406-2013	Class II	INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen...	Carl Zeiss Meditec Inc	JAD	2012-10-25
Z-0405-2013	Class II	INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen...	Carl Zeiss Meditec Inc	JAD	2012-10-25
Z-0404-2013	Class II	INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen...	Carl Zeiss Meditec Inc	JAD	2012-10-25
Z-0401-2013	Class II	BioPlant, a dental bone grafting material. BioPlant has been assigned the product code...	Sybron Dental Specialties, Inc.	LYC	2012-10-25
Z-0519-2013	Class II	Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared...	Quasar Bio-Tech Inc	ILY	2012-10-25
Z-0518-2013	Class II	Quasar MD is an infrared LED lamp that is labeled in part: "*QUASAR MD*Bringing the...	Quasar Bio-Tech Inc	ILY	2012-10-25
Z-0517-2013	Class II	Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED...	Quasar Bio-Tech Inc	ILY	2012-10-25
Z-0224-2015	Class II	Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic...	Nidek Incorporated	HQF	2012-10-24
Z-2163-2013	Class II	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used...	B Braun Medical Inc	FRN	2012-10-24
Z-0883-2013	Class II	Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography...	Philips North America LLC	KPS	2012-10-24
Z-0882-2013	Class II	Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and...	Philips North America LLC	KPS	2012-10-24
Z-0881-2013	Class II	Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model...	Philips North America LLC	JAK	2012-10-24
Z-0880-2013	Class II	Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore...	Philips North America LLC	JAK	2012-10-24
Z-0463-2013	Class II	Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative...	Sekisui Diagnostics, LLC	GGP	2012-10-24
Z-0343-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use...	Superstat Corp.	LMF	2012-10-24
Z-0342-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use...	Superstat Corp.	LMF	2012-10-24
Z-0341-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30...	Superstat Corp.	LMF	2012-10-24
Z-0340-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part#...	Superstat Corp.	LMF	2012-10-24
Z-0339-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15...	Superstat Corp.	LMF	2012-10-24
Z-0338-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use...	Superstat Corp.	LMF	2012-10-24
Z-0337-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For...	Superstat Corp.	LMF	2012-10-24
Z-0336-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use...	Superstat Corp.	LMF	2012-10-24
Z-0335-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30...	Superstat Corp.	LMF	2012-10-24
Z-0334-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use...	Superstat Corp.	LMF	2012-10-24
Z-0333-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part#...	Superstat Corp.	LMF	2012-10-24
Z-0332-2013	Class II	Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use...	Superstat Corp.	LMF	2012-10-24
Z-0331-2013	Class II	Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15...	Superstat Corp.	LMF	2012-10-24
Z-1087-2015	Class II	The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing...	Siemens Medical Solutions USA, Inc.	KPS	2012-10-23
Z-1086-2015	Class II	The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing...	Siemens Medical Solutions USA, Inc.	KPS	2012-10-23