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 545 of 1191

FDA device recalls, page 545 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1630-2017	Class II	Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1629-2017	Class II	Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1628-2017	Class II	Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1627-2017	Class II	Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1626-2017	Class II	Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1625-2017	Class II	Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1624-2017	Class II	Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1623-2017	Class II	Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1622-2017	Class II	Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1621-2017	Class II	Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1620-2017	Class II	Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1619-2017	Class II	Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1618-2017	Class II	Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1617-2017	Class II	Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1616-2017	Class II	Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1615-2017	Class II	Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1614-2017	Class II	Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1613-2017	Class II	Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1612-2017	Class II	Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1611-2017	Class II	Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1610-2017	Class II	Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1609-2017	Class II	Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1608-2017	Class II	Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1607-2017	Class II	Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1606-2017	Class II	Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1605-2017	Class II	Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1604-2017	Class II	Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1603-2017	Class II	Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1602-2017	Class II	Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1601-2017	Class II	Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1600-2017	Class II	Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1599-2017	Class II	Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1598-2017	Class II	Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1597-2017	Class II	Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1596-2017	Class II	Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1595-2017	Class II	Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1594-2017	Class II	Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1593-2017	Class II	Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1592-2017	Class II	Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1591-2017	Class II	Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1590-2017	Class II	Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1589-2017	Class II	Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1588-2017	Class II	Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1587-2017	Class II	Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1586-2017	Class II	Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1585-2017	Class II	Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1584-2017	Class II	Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1583-2017	Class II	Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1582-2017	Class II	Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1581-2017	Class II	Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09