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 544 of 1191

FDA device recalls, page 544 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1139-2017	Class II	Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from...	Encore Medical, LP	JWH	2017-01-10
Z-1044-2017	Class II	Monaco RTP System. Used to make treatment plans for patients with prescriptions for...	Elekta Limited	MUJ	2017-01-10
Z-1678-2017	Class II	Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1677-2017	Class II	Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1676-2017	Class II	Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1675-2017	Class II	Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1674-2017	Class II	Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1673-2017	Class II	Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1672-2017	Class II	Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1671-2017	Class II	Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1670-2017	Class II	Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1669-2017	Class II	Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1668-2017	Class II	Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1667-2017	Class II	Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1666-2017	Class II	Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1665-2017	Class II	Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1664-2017	Class II	Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1663-2017	Class II	Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1662-2017	Class II	Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1661-2017	Class II	Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1660-2017	Class II	Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1659-2017	Class II	Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1658-2017	Class II	Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1657-2017	Class II	Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1656-2017	Class II	Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1655-2017	Class II	Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1654-2017	Class II	Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1653-2017	Class II	Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1652-2017	Class II	Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1651-2017	Class II	Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1650-2017	Class II	Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1649-2017	Class II	Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1648-2017	Class II	Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1647-2017	Class II	Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1646-2017	Class II	Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1645-2017	Class II	Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1644-2017	Class II	Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1643-2017	Class II	Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1642-2017	Class II	Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1641-2017	Class II	Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1640-2017	Class II	Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1639-2017	Class II	Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1638-2017	Class II	Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1637-2017	Class II	Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1636-2017	Class II	Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1635-2017	Class II	Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1634-2017	Class II	Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1633-2017	Class II	Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa...	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1632-2017	Class II	Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa	Resource Optimization & Innovation, LLC	LRO	2017-01-09
Z-1631-2017	Class II	Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo	Resource Optimization & Innovation, LLC	LRO	2017-01-09