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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 232 of 1190

FDA device recalls, page 232 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0331-2023	Class I	Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST	Remel Inc	JWY	2022-10-20
Z-0330-2023	Class I	Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST	Remel Inc	JWY	2022-10-20
Z-0329-2023	Class I	Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST	Remel Inc	JWY	2022-10-20
Z-0328-2023	Class I	Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST	Remel Inc	JWY	2022-10-20
Z-0327-2023	Class I	Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST	Remel Inc	JWY	2022-10-20
Z-0322-2023	Class II	regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience...	ROi CPS LLC	OJH	2022-10-20
Z-0321-2023	Class II	regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0320-2023	Class II	regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0319-2023	Class II	regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0318-2023	Class II	regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0317-2023	Class II	regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit	ROi CPS LLC	FDE	2022-10-20
Z-0316-2023	Class II	regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0315-2023	Class II	regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0314-2023	Class II	regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience...	ROi CPS LLC	LRO	2022-10-20
Z-0313-2023	Class II	regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0312-2023	Class II	regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0311-2023	Class II	regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0310-2023	Class II	regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit	ROi CPS LLC	FDE	2022-10-20
Z-0309-2023	Class II	regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0308-2023	Class II	regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0307-2023	Class II	regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery...	ROi CPS LLC	OJH	2022-10-20
Z-0306-2023	Class II	regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0305-2023	Class II	regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience...	ROi CPS LLC	OJH	2022-10-20
Z-0304-2023	Class II	regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery...	ROi CPS LLC	OJH	2022-10-20
Z-0303-2023	Class II	regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery...	ROi CPS LLC	OEZ	2022-10-20
Z-0302-2023	Class II	regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0301-2023	Class II	regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0300-2023	Class II	regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0299-2023	Class II	regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0298-2023	Class II	regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0297-2023	Class II	regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0296-2023	Class II	regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0295-2023	Class II	regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0294-2023	Class II	regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience...	ROi CPS LLC	OJH	2022-10-20
Z-0293-2023	Class II	regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit	ROi CPS LLC	OGR	2022-10-20
Z-0292-2023	Class II	regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0291-2023	Class II	regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0290-2023	Class II	regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit	ROi CPS LLC	OJK	2022-10-20
Z-0289-2023	Class II	regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0288-2023	Class II	regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0287-2023	Class II	regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0286-2023	Class II	regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0285-2023	Class II	regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0284-2023	Class II	regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit	ROi CPS LLC	OJH	2022-10-20
Z-0283-2023	Class II	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	ROi CPS LLC	OJG	2022-10-20
Z-0223-2023	Class II	NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540	CooperSurgical, Inc.	JAY	2022-10-20
Z-0342-2023	Class II	CMV IgM EIA, in vitro diagnostic.	Bio-Rad Laboratories Inc.	LFZ	2022-10-19
Z-0235-2023	Class II	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Atrium Medical Corporation	KDQ	2022-10-18
Z-0231-2023	Class II	Hill-Rom Progressa Bed System	Baxter Healthcare Corporation	FNL	2022-10-18
Z-0456-2023	Class I	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DSP	2022-10-17