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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 481 of 1191

FDA device recalls, page 481 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1335-2018	Class II	AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3)...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-22
Z-1334-2018	Class II	Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN)...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYB	2017-12-22
Z-1333-2018	Class II	ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3)...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-22
Z-1332-2018	Class II	(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-12-22
Z-1331-2018	Class II	(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2017-12-22
Z-1330-2018	Class II	(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQX	2017-12-22
Z-1329-2018	Class II	(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYB	2017-12-22
Z-1328-2018	Class II	Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number...	Arrow International LLC (subsidiary of Teleflex Incorporated)	NIE	2017-12-22
Z-1327-2018	Class II	Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1)...	Arrow International LLC (subsidiary of Teleflex Incorporated)	JLS	2017-12-22
Z-1749-2018	Class II	LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE...	DePuy Mitek, Inc.	LXH	2017-12-22
Z-1326-2018	Class II	AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-22
Z-1325-2018	Class II	Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2017-12-22
Z-1324-2018	Class II	(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-22
Z-1323-2018	Class II	(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-22
Z-1311-2018	Class II	Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT...	Roche Diagnostics GmbH	PMT	2017-12-22
Z-0566-2018	Class II	Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only	Medtronic Sofamor Danek USA Inc	MDM	2017-12-22
Z-2257-2018	Class III	Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus...	Quantimetrix Corp.	JJW	2017-12-21
Z-2057-2018	Class II	3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The...	Stryker Corp.	PPR	2017-12-21
Z-1351-2018	Class II	Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with...	W & H DentalWerk Buermoos GmbH	EBW	2017-12-21
Z-1152-2018	Class II	ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2017-12-21
Z-2567-2018	Class II	Custom Made Implant System with Minimum Invasive Grower (MIG) component	Howmedica Osteonics Corp	JDO	2017-12-21
Z-1219-2018	Class II	(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN...	Depuy Orthopaedics Inc.	HRY	2017-12-21
Z-0411-2018	Class II	MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541	Baxter Healthcare Corporation	FLD	2017-12-21
Z-2823-2018	Class II	Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient...	Merit Medical Systems, Inc.	FJS	2017-12-20
Z-1938-2018	Class II	Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment...	AD-Tech Medical Instrument Corp.	LXH	2017-12-20
Z-1463-2018	Class II	The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under...	Integra LifeSciences Corporation	HWT	2017-12-20
Z-1348-2018	Class II	AUTO REF/KERATOMETER ARK-1s	Nidek Incorporated	HKO	2017-12-20
Z-1419-2018	Class III	Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI...	OraSure Technologies, Inc.	DIO	2017-12-20
Z-1133-2018	Class II	SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600	Boston Scientific Corporation	FBN	2017-12-20
Z-1235-2018	Class II	ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL...	Zimmer GmbH	HSB	2017-12-20
Z-1234-2018	Class II	ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN...	Zimmer GmbH	HSB	2017-12-20
Z-1233-2018	Class II	ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR...	Zimmer GmbH	HSB	2017-12-20
Z-1232-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER...	Zimmer GmbH	HSB	2017-12-20
Z-1231-2018	Class II	ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG...	Zimmer GmbH	HSB	2017-12-20
Z-1230-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER...	Zimmer GmbH	HSB	2017-12-20
Z-1229-2018	Class II	ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG...	Zimmer GmbH	HSB	2017-12-20
Z-1228-2018	Class II	ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is...	Zimmer GmbH	HSB	2017-12-20
Z-1227-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X...	Zimmer GmbH	HSB	2017-12-20
Z-1226-2018	Class II	ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP...	Zimmer GmbH	HSB	2017-12-20
Z-1225-2018	Class II	ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X...	Zimmer GmbH	HSB	2017-12-20
Z-0717-2018	Class II	Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura...	Philips North America LLC	OWB	2017-12-20
Z-0622-2018	Class II	Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic...	Medtronic Neurosurgery	HBO	2017-12-20
Z-2264-2020	Class III	PerkinElmer 226 Sample Collection Device	Revvity Health Sciences, Inc.	PJC	2017-12-19
Z-2261-2018	Class II	P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and...	Paragon 28	JDR	2017-12-19
Z-1876-2018	Class II	Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is...	Nipro Medical Corporation	FJK	2017-12-19
Z-1188-2018	Class II	1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number...	Cook Incorporated	MQF	2017-12-19
Z-1187-2018	Class II	Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number...	Cook Incorporated	MQF	2017-12-19
Z-1186-2018	Class II	Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900...	Cook Incorporated	MQF	2017-12-19
Z-1185-2018	Class II	Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number...	Cook Incorporated	KYZ	2017-12-19
Z-0589-2018	Class I	Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR...	Medtronic, Inc.	LWS	2017-12-19