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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 753 of 1191

FDA device recalls, page 753 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1653-2013	Class II	Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic...	Penlon, Ltd.	CAD	2013-05-14
Z-1515-2013	Class II	ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	JIT	2013-05-14
Z-1514-2013	Class II	ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in...	Siemens Healthcare Diagnostics Inc.	JIT	2013-05-14
Z-1513-2013	Class II	ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in...	Siemens Healthcare Diagnostics Inc.	CEW	2013-05-14
Z-1512-2013	Class II	ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use...	Siemens Healthcare Diagnostics Inc.	CEW	2013-05-14
Z-1441-2013	Class III	Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended...	Optovue Inc.	HLI	2013-05-14
Z-1542-2013	Class II	QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and...	Edwards Lifesciences LLC	DWS	2013-05-14
Z-1443-2013	Class II	Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850...	GE Healthcare	BSZ	2013-05-14
Z-1097-2016	Class II	NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm...	Collagen Matrix, Inc	NPM	2013-05-13
Z-2085-2013	Class II	HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is...	Life Technologies Corporation	NYQ	2013-05-13
Z-1945-2013	Class II	Siemens AXIOM Artis zeego x-ray, angiographic system	Siemens Medical Solutions USA, Inc.	IZI	2013-05-13
Z-1530-2013	Class II	ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek...	Ethicon Endo-Surgery Inc	GDW	2013-05-13
Z-1486-2013	Class II	Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product...	MEDLINE INDUSTRIES, LP - Northfield	GAM	2013-05-13
Z-1436-2013	Class I	Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843...	Endologix LLC	DYB	2013-05-13
Z-1563-2013	Class II	Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is...	Microgenics Corporation	JJX	2013-05-13
Z-1450-2014	Class II	400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger...	ErgoSafe Product LLC dba Prism Medical Services	FSA	2013-05-10
Z-1961-2013	Class II	Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)	ZimVie US Corp LLC	DZE	2013-05-10
Z-1927-2013	Class II	Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with...	SPINEFRONTIER, Inc. dba LESspine Innovations	HXX	2013-05-10
Z-2213-2013	Class II	Responder 5 is a nurse call communication system that connects patients with staff in a...	Rauland-Borg Corporation	ILQ	2013-05-10
Z-1462-2013	Class I	Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1461-2013	Class I	Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1460-2013	Class I	Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1459-2013	Class I	Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)(...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1458-2013	Class I	Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1457-2013	Class I	Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1456-2013	Class I	Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1455-2013	Class I	Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1454-2013	Class I	Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1453-2013	Class I	Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side)...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1452-2013	Class I	Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME...	Symbios Medical Products, LLC	MEB	2013-05-10
Z-1886-2013	Class II	IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-1885-2013	Class II	IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-1884-2013	Class II	Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-1883-2013	Class II	Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-1882-2013	Class II	Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-1881-2013	Class II	ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500...	Siemens Healthcare Diagnostics Inc.	JLW	2013-05-10
Z-0433-2014	Class II	syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data...	Siemens Healthcare Diagnostics Inc.	NSX	2013-05-10
Z-1960-2013	Class II	Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)	ZimVie US Corp LLC	DZE	2013-05-10
Z-2151-2016	Class II	NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad...	Novarad Corp.	LLZ	2013-05-09
Z-1599-2013	Class II	Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI...	ConBio, a CynoSure Company	GEX	2013-05-09
Z-1736-2013	Class II	Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal...	Integra LifeSciences Corporation	HSB	2013-05-09
Z-1615-2013	Class III	VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990...	Ortho-Clinical Diagnostics, Inc.	DCK	2013-05-09
Z-1614-2013	Class III	VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596...	Ortho-Clinical Diagnostics, Inc.	CEM	2013-05-09
Z-1551-2013	Class II	GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any...	GE Healthcare	JAK	2013-05-09
Z-1442-2013	Class II	8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed...	Intuitive Surgical, Inc.	NAY	2013-05-08
Z-1433-2013	Class II	8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System...	Intuitive Surgical, Inc.	NAY	2013-05-08
Z-1432-2013	Class II	8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model...	Intuitive Surgical, Inc.	NAY	2013-05-08
Z-1431-2013	Class II	8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model...	Intuitive Surgical, Inc.	NAY	2013-05-08
Z-1558-2013	Class I	GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable...	Verathon Inc.	CCW	2013-05-08
Z-1331-2013	Class III	DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are...	Depuy Orthopaedics Inc.	FYE	2013-05-08