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 535 of 1191

FDA device recalls, page 535 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0879-2018	Class II	LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0878-2018	Class II	LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0877-2018	Class II	LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0876-2018	Class II	LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0875-2018	Class II	LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0874-2018	Class II	LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0873-2018	Class II	LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0872-2018	Class II	LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0871-2018	Class II	LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0870-2018	Class II	LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0869-2018	Class II	LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0868-2018	Class II	LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0867-2018	Class II	LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0866-2018	Class II	LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0865-2018	Class II	LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0864-2018	Class II	LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0863-2018	Class II	LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0862-2018	Class II	LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0861-2018	Class II	LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0860-2018	Class II	LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0859-2018	Class II	LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0858-2018	Class II	LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0857-2018	Class II	LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0856-2018	Class II	LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0855-2018	Class II	LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0854-2018	Class II	LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0853-2018	Class II	LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0852-2018	Class II	LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0851-2018	Class II	LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-1771-2017	Class II	ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized...	Cardiovascular Systems Incorporated	MCW	2017-03-03
Z-1766-2017	Class II	The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used...	Merit Medical Systems, Inc.	DXC	2017-03-03
Z-1539-2017	Class II	Panta Nail, Rx only, Sterile,	Integra LifeSciences Corporation	HSB	2017-03-03
Z-1703-2017	Class II	Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab...	Siemens Healthcare Diagnostics Inc.	JJE	2017-03-03
Z-1852-2017	Class II	It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part...	Verathon Inc.	CCW	2017-03-03
Z-1705-2017	Class II	The CG+ Arrow PIC Catheters permit venous access to the central circulation through a...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2017-03-03
Z-1745-2017	Class II	Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity...	Medtronic, Inc.	NAD	2017-03-03
Z-1744-2017	Class II	Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item...	Medtronic, Inc.	NAD	2017-03-03
Z-1743-2017	Class II	Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium...	Medtronic, Inc.	NAD	2017-03-03
Z-1742-2017	Class II	Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity...	Medtronic, Inc.	MGQ	2017-03-03
Z-1741-2017	Class II	Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists...	Medtronic, Inc.	HMP	2017-03-03
Z-1740-2017	Class II	Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code...	Medtronic, Inc.	HMP	2017-03-03
Z-1739-2017	Class II	Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists...	Medtronic, Inc.	HMP	2017-03-03
Z-0637-2022	Class III	LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit...	Microbiologics, Inc.	JTR	2017-03-02
Z-0636-2022	Class III	KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit...	Microbiologics, Inc.	JTR	2017-03-02
Z-2891-2018	Class II	Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a...	Wenzel Spine	LLZ	2017-03-02
Z-2779-2017	Class II	Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm...	Myelotec, Inc.	HRX	2017-03-02
Z-1708-2017	Class II	eCare Coordinator Product Usage: is software intended for use in data aggregation...	Visicu, Inc.	DRG	2017-03-02
Z-1478-2017	Class II	Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical...	Inion Oy	NPK	2017-03-01
Z-1764-2017	Class II	Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx	Roche Diagnostics GmbH	JQP	2017-03-01
Z-1763-2017	Class II	Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx	Roche Diagnostics GmbH	JQP	2017-03-01