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 257 of 1190

FDA device recalls, page 257 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1187-2022	Class II	SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363	Busse Hospital Disposables	FBQ	2022-02-22
Z-1186-2022	Class II	4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362	Busse Hospital Disposables	FBQ	2022-02-22
Z-1185-2022	Class II	4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360	Busse Hospital Disposables	FBQ	2022-02-22
Z-1184-2022	Class II	SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1	Busse Hospital Disposables	FBQ	2022-02-22
Z-1183-2022	Class II	SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354	Busse Hospital Disposables	FBQ	2022-02-22
Z-1182-2022	Class II	SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1	Busse Hospital Disposables	FBQ	2022-02-22
Z-1181-2022	Class II	SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352	Busse Hospital Disposables	FBQ	2022-02-22
Z-1180-2022	Class II	"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351	Busse Hospital Disposables	FBQ	2022-02-22
Z-1179-2022	Class II	3.2MM Pellet Insertion Tray Catalog Number: B1144	Busse Hospital Disposables	FBQ	2022-02-22
Z-1178-2022	Class II	Procedural Accessory Kit Catalog Number: 9665R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1177-2022	Class II	Bone Marrow Biopsy Tray Catalog Number: 8917R1	Busse Hospital Disposables	PRV	2022-02-22
Z-1176-2022	Class II	Core Biopsy Tray Catalog Number: 8673R4	Busse Hospital Disposables	FCH	2022-02-22
Z-1175-2022	Class II	Joint Injection Tray Catalog Number: 8561R1	Busse Hospital Disposables	OGJ	2022-02-22
Z-1174-2022	Class II	Single Shot Epidural Tray - 18G Catalog Number: 8139R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1173-2022	Class II	Pump Refill Kit Catalog Number: 7347R1	Busse Hospital Disposables	OGJ	2022-02-22
Z-1172-2022	Class II	Single Shot Epidural Tray Catalog Number: 6797R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1171-2022	Class II	Nerve Block Tray Catalog Number: 6796R3	Busse Hospital Disposables	OGJ	2022-02-22
Z-1170-2022	Class II	Sterile Epidural Tray Catalog Number: 6259R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1169-2022	Class II	Single Shot Epidural Tray Catalog Number: 6183R1	Busse Hospital Disposables	OGJ	2022-02-22
Z-1168-2022	Class II	Cervical Tray Catalog Number: 3765R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1167-2022	Class II	Nerve Block Tray Catalog Number: 3764R2	Busse Hospital Disposables	OGJ	2022-02-22
Z-1166-2022	Class II	CVC Dressing Change Kit Catalog Number: 2491R1	Busse Hospital Disposables	MCY	2022-02-22
Z-1165-2022	Class II	Stereo Breast Biopsy Tray Catalog Number: 2383R1	Busse Hospital Disposables	FCH	2022-02-22
Z-1164-2022	Class II	Pain Tray Catalog Number: 9883	Busse Hospital Disposables	OGJ	2022-02-22
Z-1163-2022	Class II	MBB Tray Catalog Number: 9882	Busse Hospital Disposables	OGJ	2022-02-22
Z-1162-2022	Class II	Universal Nerve Block Tray Catalog Number: 9818	Busse Hospital Disposables	OGJ	2022-02-22
Z-1161-2022	Class II	Universal Nerve Block Tray Catalog Number: 9779	Busse Hospital Disposables	OGJ	2022-02-22
Z-1160-2022	Class II	Nerve Block Tray Catalog Number: 9342	Busse Hospital Disposables	OGJ	2022-02-22
Z-1159-2022	Class II	Single Shot Epidural Tray Catalog Number: 8417	Busse Hospital Disposables	OGJ	2022-02-22
Z-1158-2022	Class II	Nerve Block Tray Catalog Number: 8415	Busse Hospital Disposables	OGJ	2022-02-22
Z-1157-2022	Class II	I.V. Start Kit Catalog 8172	Busse Hospital Disposables	LRS	2022-02-22
Z-1156-2022	Class II	Port Tray Catalog 7607	Busse Hospital Disposables	OGJ	2022-02-22
Z-1155-2022	Class II	Epidural Tray Catalog 1577	Busse Hospital Disposables	OGJ	2022-02-22
Z-1154-2022	Class II	Universal Tray Catalog 1567	Busse Hospital Disposables	OGJ	2022-02-22
Z-1153-2022	Class II	Epidural Tray Catalog 1307	Busse Hospital Disposables	OGJ	2022-02-22
Z-1152-2022	Class II	Single Shot Epidural Tray Catalog 1292	Busse Hospital Disposables	OGJ	2022-02-22
Z-1151-2022	Class II	Single Shot Epidural Tray Catalog 1165	Busse Hospital Disposables	OGJ	2022-02-22
Z-1150-2022	Class II	Lumbar Tray Catalog 1091	Busse Hospital Disposables	FMJ	2022-02-22
Z-1149-2022	Class II	Cervical Tray Catalog 1089	Busse Hospital Disposables	OGJ	2022-02-22
Z-1148-2022	Class II	Procedure Tray Catalog 1065	Busse Hospital Disposables	OGJ	2022-02-22
Z-1147-2022	Class II	I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822	Busse Hospital Disposables	LRS	2022-02-22
Z-0899-2022	Class II	iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number...	ConforMIS, Inc.	JWH	2022-02-22
Z-1015-2022	Class II	IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and...	Siemens Healthcare Diagnostics Inc.	DHA	2022-02-22
Z-1014-2022	Class II	ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS...	Instrumentation Laboratory Co.	GKP	2022-02-22
Z-1041-2022	Class II	Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and...	Philips North America LLC	MWI	2022-02-22
Z-0854-2022	Class II	Illumina NextSeq 550Dx, REF: 20005715, CE, IVD	Illumina, Inc.	PFF	2022-02-22
Z-1017-2022	Class II	Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)	Freudenberg Medical, LLC	DYB	2022-02-21
Z-1016-2022	Class II	Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)	Freudenberg Medical, LLC	DYB	2022-02-21
Z-0856-2022	Class II	Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm	SA3, LLC	OLR	2022-02-21
Z-0829-2022	Class II	Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko...	Baxter Healthcare Corporation	FSA	2022-02-21