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 778 of 1190

FDA device recalls, page 778 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0704-2013	Class II	GE Healthcare Definium 5000/5220493-2 X-Ray System	GE Healthcare	JAC	2012-09-26
Z-0703-2013	Class II	GE Healthcare Definium 5000 / 5220493 X-Ray System	GE Healthcare	JAC	2012-09-26
Z-0072-2013	Class II	*This recall is being conducted due to an incomplete recall for RES 57829* Curlin...	Zevex, Inc.	FRN	2012-09-26
Z-0168-2013	Class II	ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation...	Alphatec Spine, Inc.	MNH	2012-09-25
Z-0078-2013	Class II	Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical...	Teleflex Medical	FZP	2012-09-25
Z-0657-2013	Class II	(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel...	STRYKER Communications, Inc.	FSY	2012-09-25
Z-0050-2013	Class II	Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is...	Terumo Cardiovascular Systems Corporation	KFM	2012-09-25
Z-0049-2013	Class II	Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System...	Terumo Cardiovascular Systems Corporation	KFM	2012-09-25
Z-0285-2013	Class II	Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0284-2013	Class II	Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0283-2013	Class II	Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0282-2013	Class II	Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0281-2013	Class II	Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0280-2013	Class II	Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0058-2013	Class II	Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.	Belmont Medical Technologies	FRN	2012-09-25
Z-0131-2013	Class II	Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0130-2013	Class II	Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0129-2013	Class II	Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0128-2013	Class II	Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0127-2013	Class II	Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0126-2013	Class II	Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-25
Z-0780-2013	Class II	Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO...	Champion Mfg, Inc.	INM	2012-09-24
Z-0779-2013	Class II	Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO...	Champion Mfg, Inc.	INM	2012-09-24
Z-0778-2013	Class II	PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST...	Champion Mfg, Inc.	INM	2012-09-24
Z-0528-2013	Class II	Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in...	Datascope Corp.	MHX	2012-09-24
Z-0777-2013	Class II	PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST...	Champion Mfg, Inc.	INM	2012-09-24
Z-0187-2013	Class II	ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA...	Varian Medical Systems, Inc.	IYE	2012-09-24
Z-0132-2013	Class II	Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no...	Greatbatch Medical	DYB	2012-09-24
Z-0053-2013	Class II	Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is...	Terumo Cardiovascular Systems Corporation	KFM	2012-09-24
Z-0052-2013	Class II	Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is...	Terumo Cardiovascular Systems Corporation	KFM	2012-09-24
Z-0051-2013	Class II	Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is...	Terumo Cardiovascular Systems Corporation	KFM	2012-09-24
Z-0609-2013	Class II	Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the...	Sanofi Aventis U.S., LLC		2012-09-21
Z-0437-2013	Class II	NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system...	Zimmer GmbH	JWH	2012-09-21
Z-2424-2012	Class II	Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2423-2012	Class II	Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2422-2012	Class II	Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2421-2012	Class II	Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2420-2012	Class II	Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2419-2012	Class II	Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2418-2012	Class II	Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter	Asahi Kasei Medical Co., Ltd., Okatomi Plant	KDI	2012-09-21
Z-2257-2013	Class II	GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5...	GE Healthcare	LLZ	2012-09-20
Z-0661-2013	Class II	STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are...	Advanced Sterilization Products	MLR	2012-09-20
Z-0645-2013	Class II	ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2	Horiba Instruments Incorporated	JQP	2012-09-20
Z-0413-2013	Class II	CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II...	CAPTIVA SPINE, Inc.	MNI	2012-09-20
Z-0200-2013	Class II	GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head...	GE Healthcare	OXO	2012-09-20
Z-0199-2013	Class II	GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human...	GE Healthcare	OXO	2012-09-20
Z-0198-2013	Class II	GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human...	GE Healthcare	OXO	2012-09-20
Z-0197-2013	Class II	GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic...	GE Healthcare	OXO	2012-09-20
Z-0659-2013	Class II	The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx...	Zimmer GmbH	MAX	2012-09-20
Z-0416-2013	Class II	The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile...	Zimmer GmbH	LPH	2012-09-20