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 779 of 1190

FDA device recalls, page 779 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0532-2013	Class II	Medline Total Knee CDS; a single patient prescription procedure pack and disposables...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2012-09-20
Z-0167-2013	Class II	SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131...	LivaNova USA, Inc.	DWA	2012-09-20
Z-0166-2013	Class II	SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121...	LivaNova USA, Inc.	DWA	2012-09-20
Z-2449-2012	Class II	Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-20
Z-0083-2014	Class II	Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft...	Medtronic, Inc.	MIH	2012-09-19
Z-0275-2013	Class II	Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is...	LivaNova USA, Inc.	DTQ	2012-09-19
Z-0274-2013	Class II	S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is...	LivaNova USA, Inc.	DTQ	2012-09-19
Z-0273-2013	Class II	S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is...	LivaNova USA, Inc.	DTQ	2012-09-19
Z-0272-2013	Class II	S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is...	LivaNova USA, Inc.	DTQ	2012-09-19
Z-0271-2013	Class II	S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is...	LivaNova USA, Inc.	DTQ	2012-09-19
Z-0077-2013	Class II	Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are...	Hill-Rom Inc.	FSY	2012-09-19
Z-0004-2013	Class II	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed...	Cure Medical, LLC	EZD	2012-09-19
Z-1328-2013	Class II	Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number...	International Remote Imaging Systems	JJW	2012-09-18
Z-1095-2013	Class II	CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage...	Trophy	EAP	2012-09-18
Z-1094-2013	Class II	CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage...	Trophy	EAP	2012-09-18
Z-1000-2013	Class II	CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use)...	Trophy	EAP	2012-09-18
Z-0999-2013	Class II	CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use)...	Trophy	EAP	2012-09-18
Z-0701-2013	Class II	Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number...	Becton Dickinson & Co	NJR	2012-09-18
Z-0922-2013	Class II	Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended...	Instratek, Incorporated	NBH	2012-09-18
Z-0786-2013	Class II	Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical...	Philips North America LLC	JAK	2012-09-18
Z-0169-2013	Class II	MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for...	Elekta Limited	IYE	2012-09-18
Z-0108-2014	Class II	Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0107-2014	Class II	Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0106-2014	Class II	Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0105-2014	Class II	Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0104-2014	Class II	Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0103-2014	Class II	Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0102-2014	Class II	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are...	Siemens Healthcare Diagnostics Inc.	CHL	2012-09-17
Z-0081-2013	Class II	Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended...	Boston Scientific Corporation	JOS	2012-09-17
Z-0080-2013	Class II	Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar...	Boston Scientific Corporation	JOS	2012-09-17
Z-0079-2013	Class II	LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25)...	Boston Scientific Corporation	GEI	2012-09-17
Z-2466-2012	Class II	BariAir Therapy System The BariAir Therapy System is a risk management treatment system...	KCI USA, Inc.	FNL	2012-09-17
Z-0731-2014	Class II	Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The...	GE Healthcare	LLZ	2012-09-15
Z-0776-2013	Class II	Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for...	Zimmer GmbH	MRA	2012-09-14
Z-0775-2013	Class II	Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for...	Zimmer GmbH	LPH	2012-09-14
Z-0774-2013	Class II	Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is...	Zimmer GmbH	MRA	2012-09-14
Z-0773-2013	Class II	Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated...	Zimmer GmbH	LPH	2012-09-14
Z-0772-2013	Class II	Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either...	Zimmer GmbH	LPH	2012-09-14
Z-0771-2013	Class II	Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated...	Zimmer GmbH	LPH	2012-09-14
Z-0770-2013	Class II	Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM...	Zimmer GmbH	MEH	2012-09-14
Z-0769-2013	Class II	Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM...	Zimmer GmbH	LPH	2012-09-14
Z-0429-2013	Class III	Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low...	Horiba Instruments Incorporated	JPK	2012-09-14
Z-0289-2013	Class III	ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers...	Horiba Instruments Incorporated	CGX	2012-09-14
Z-0158-2013	Class II	Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers...	LivaNova USA, Inc.	DTL	2012-09-14
Z-0157-2013	Class II	Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot...	LivaNova USA, Inc.	DTL	2012-09-14
Z-0663-2013	Class II	Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom...	Merit Medical Systems, Inc.	NGT	2012-09-14
Z-0112-2013	Class II	AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit...	Advandx, Inc.	JSS	2012-09-14
Z-0116-2013	Class II	AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit...	Advandx, Inc.	JSS	2012-09-14
Z-2453-2012	Class II	Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The...	Hologic, Inc.	JAA	2012-09-14
Z-2452-2012	Class II	Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The...	Hologic, Inc.	JAA	2012-09-14