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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 555 of 1191

FDA device recalls, page 555 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0673-2017	Class II	MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b...	Roche Diagnostics GmbH	CDS	2016-10-31
Z-1145-2017	Class III	HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid...	Abbott Medical	LGZ	2016-10-31
Z-0409-2017	Class II	MEVION S250 Product Usage: Proton Radiation Therapy	Mevion Medical Systems, Inc.	MUJ	2016-10-31
Z-2109-2018	Class II	12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used...	Ion Beam Applications S.A.	LHN	2016-10-28
Z-1053-2017	Class II	Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S...	The Binding Site Group Ltd.	DEH	2016-10-28
Z-0947-2017	Class II	Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged...	Aesculap Inc	HFX	2016-10-28
Z-0752-2017	Class II	Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are...	Miltex, Inc.	LRW	2016-10-28
Z-0751-2017	Class II	Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic...	Miltex, Inc.	GEN	2016-10-28
Z-0655-2017	Class II	SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22...	Hologic, Inc.	HHM	2016-10-28
Z-0770-2017	Class II	Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide...	Natus Medical Incorporated	LBI	2016-10-28
Z-0898-2017	Class II	Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe...	Teleflex Medical	CCQ	2016-10-27
Z-0680-2017	Class II	Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray...	Evident Scientific MIS, Inc.	RBY	2016-10-27
Z-0386-2017	Class II	LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical...	Teleflex Medical	CCQ	2016-10-27
Z-0385-2017	Class II	LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These...	Teleflex Medical	BTR	2016-10-27
Z-0384-2017	Class II	LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products...	Teleflex Medical	CCT	2016-10-27
Z-0383-2017	Class II	FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical...	Teleflex Medical	CCQ	2016-10-27
Z-0382-2017	Class II	FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for...	Teleflex Medical	CCQ	2016-10-27
Z-0381-2017	Class II	LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of...	Teleflex Medical	CCQ	2016-10-27
Z-0959-2017	Class II	Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided...	Brainlab, Inc.	OLO	2016-10-27
Z-1520-2018	Class III	Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification...	Ortho-Clinical Diagnostics, Inc.	CEW	2016-10-26
Z-0864-2017	Class III	VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit)...	Ortho-Clinical Diagnostics, Inc.	DCK	2016-10-26
Z-0701-2017	Class II	3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal...	3M Company	GEI	2016-10-26
Z-0583-2017	Class II	Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0582-2017	Class II	Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0581-2017	Class II	Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0580-2017	Class II	Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0579-2017	Class II	Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0578-2017	Class II	Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0577-2017	Class II	Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate...	Atrium Medical Corporation	GBZ	2016-10-26
Z-0576-2017	Class II	Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate...	Atrium Medical Corporation	GBZ	2016-10-26
Z-1395-2017	Class II	SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part...	Med-el Elektromedizinische Geraete, GmbH	ISM	2016-10-25
Z-1105-2017	Class II	NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder...	Abbott Medical	LHC	2016-10-25
Z-0900-2017	Class II	Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit	Exactech, Inc.	KWT	2016-10-25
Z-0622-2017	Class II	Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row...	Canon Medical Systems USA, Inc.	JAK	2016-10-25
Z-0768-2017	Class II	MicroScan LabPro Data Management System. Intended to manage both microbial...	Siemens Healthcare Diagnostics Inc.	OUG	2016-10-25
Z-0650-2017	Class II	ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile...	Depuy Orthopaedics Inc.	MEH	2016-10-25
Z-0391-2017	Class II	OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table...	Hill-Rom Inc.	JEA	2016-10-25
Z-0893-2017	Class II	Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama...	Ansell Healthcare Products LLC	KGO	2016-10-24
Z-0690-2017	Class II	FMsealer Open Shears. Model FM3001	Omni-Guide Holdings, Inc.	GEI	2016-10-24
Z-0408-2017	Class II	Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is...	Siemens Healthcare Diagnostics Inc.	JJX	2016-10-24
Z-0407-2017	Class II	Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase...	Siemens Healthcare Diagnostics Inc.	JIS	2016-10-24
Z-2922-2018	Class III	is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA)...	Svar Life Science AB	LKJ	2016-10-21
Z-2921-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection...	Svar Life Science AB	MID	2016-10-21
Z-2920-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection...	Svar Life Science AB	MID	2016-10-21
Z-2919-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection...	Svar Life Science AB	LKO	2016-10-21
Z-0723-2017	Class II	ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.	Siemens Healthcare Diagnostics Inc.	GKZ	2016-10-21
Z-0659-2017	Class I	5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart...	SynCardia Systems LLC	LOZ	2016-10-21
Z-0647-2017	Class I	Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med...	Centurion Medical Products, LP	FOZ	2016-10-21
Z-0410-2017	Class II	MEVION S250 Product Usage: Proton Radiation Therapy System	Mevion Medical Systems, Inc.	MUJ	2016-10-21
Z-2391-2018	Class II	NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat...	Ekla Corporation	JHI	2016-10-20