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 546 of 1191

FDA device recalls, page 546 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1580-2017	Class II	Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1579-2017	Class II	Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1578-2017	Class II	Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1577-2017	Class II	Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1576-2017	Class II	Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1575-2017	Class II	Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1574-2017	Class II	Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1573-2017	Class II	Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1572-2017	Class II	Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1571-2017	Class II	Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1570-2017	Class II	Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1569-2017	Class II	Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1568-2017	Class II	Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1567-2017	Class II	Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1566-2017	Class II	Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1565-2017	Class II	Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1564-2017	Class II	Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1563-2017	Class II	Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1562-2017	Class II	Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1561-2017	Class II	Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1560-2017	Class II	Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1559-2017	Class II	Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1558-2017	Class II	Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1557-2017	Class II	Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1556-2017	Class II	Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1555-2017	Class II	Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1554-2017	Class II	Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1553-2017	Class II	Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1552-2017	Class II	Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1551-2017	Class II	Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1550-201	Class II	Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1549-2017	Class II	Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1548-201	Class II	Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1547-2017	Class II	Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1546-2017	Class II	Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1545-2017	Class II	Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1544-2017	Class II	Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1218-2017	Class II	GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories	Aesculap Inc	GEI	2017-01-09
Z-1197-2017	Class II	STERRAD NX Sterilization System, Product Code: 10033, 10033-002	Advanced Sterilization Products	MLR	2017-01-09
Z-1873-2017	Class II	Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister...	Laerdal Medical a/S	JCX	2017-01-08
Z-1036-2017	Class II	Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta...	Evident Scientific MIS, Inc.	RBY	2017-01-07
Z-1477-2017	Class II	C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical...	PENTAX of America, Inc.	GEH	2017-01-06
Z-1404-2017	Class II	Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition...	The See Clear Company	LPL	2017-01-06
Z-1096-2017	Class II	Hitachi Oasis MRI System - C-Spine Coil	FUJIFILM Healthcare Americas Corporation	LNH	2017-01-06
Z-2317-2017	Class II	DePuy Synthes various orthopedic instruments modified by U.S. Distributors These...	Depuy Orthopaedics Inc.	LXH	2017-01-06
Z-1500-2017	Class II	EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses...	Haag-Streit USA Inc	NFJ	2017-01-05
Z-1181-2017	Class III	VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in...	Ortho-Clinical Diagnostics, Inc.	JIT	2017-01-05
Z-1108-2017	Class II	Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative...	Wallac Oy	KHO	2017-01-05
Z-1107-2017	Class II	Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in...	Wallac Oy	KHO	2017-01-05
Z-1049-2017	Class II	AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F...	Endologix LLC	MIH	2017-01-04