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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 301 of 1190

FDA device recalls, page 301 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1352-2021	Class II	EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product...	Acucon	LPL	2021-02-16
Z-1268-2021	Class II	Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage...	Carestream Dental LLC	NOF	2021-02-15
Z-1351-2021	Class II	NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1350-2021	Class II	NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1201-2021	Class I	Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the...	Medtronic, Inc.	MIH	2021-02-12
Z-1267-2021	Class II	VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2...	Ortho-Clinical Diagnostics, Inc.	QKP	2021-02-12
Z-1266-2021	Class II	VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The...	Ortho-Clinical Diagnostics, Inc.	QKP	2021-02-12
Z-1349-2021	Class II	NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1325-2021	Class II	PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1324-2021	Class II	Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1323-2021	Class II	PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture...	NuVasive Specialized Orthopedics, Inc.	HSB	2021-02-12
Z-1298-2021	Class II	PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile...	Teleflex Medical	GBX	2021-02-12
Z-1264-2021	Class II	Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100	Imactis, SAS	JAK	2021-02-11
Z-1296-2021	Class II	Operating Table System	Getinge Group Logistics America, LLC	FQO	2021-02-11
Z-1311-2021	Class II	Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories)...	Hollister Incorporated	KNT	2021-02-11
Z-1256-2021	Class II	Judkins Pack	Medtronic, Inc.	OEQ	2021-02-11
Z-1257-2021	Class I	PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC...	Cordis US Corp.	NIM	2021-02-11
Z-1186-2021	Class II	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated...	Howmedica Osteonics Corp	MBH	2021-02-10
Z-0081-2022	Class II	Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A	Philips North America LLC	MKJ	2021-02-09
Z-0080-2022	Class II	Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A	Philips North America LLC	MKJ	2021-02-09
Z-0079-2022	Class II	Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304	Philips North America LLC	MKJ	2021-02-09
Z-0078-2022	Class II	Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A	Philips North America LLC	MKJ	2021-02-09
Z-1283-2021	Class II	In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive...	In2Bones SAS	GFF	2021-02-09
Z-1252-2021	Class II	Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A...	Medtronic, Inc.	FMI	2021-02-09
Z-1251-2021	Class II	McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle...	Medtronic, Inc.	FMI	2021-02-09
Z-1250-2021	Class II	Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle...	Medtronic, Inc.	FMI	2021-02-09
Z-1366-2021	Class II	SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult	SharpMed, LLC	GCJ	2021-02-08
Z-1299-2021	Class II	The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum...	Meridian Bioscience Inc	LJZ	2021-02-08
Z-1274-2021	Class II	Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2	Siemens Healthcare Diagnostics Inc.	MYF	2021-02-08
Z-1293-2021	Class II	Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand...	Mizuho Orthopedic Systems Inc	GDC	2021-02-08
Z-1547-2021	Class II	NM/CT 870 DR Nuclear Medicine / CT Scanners	GE Healthcare	KPS	2021-02-07
Z-1546-2021	Class II	NM/CT 860 Nuclear Medicine / CT Scanners	GE Healthcare	KPS	2021-02-07
Z-1545-2021	Class II	NM/CT 850 Nuclear Medicine / CT Scanners	GE Healthcare	KPS	2021-02-07
Z-1176-2021	Class II	System INFX-8000F	Canon Medical Systems USA, Inc.	MQB	2021-02-05
Z-1175-2021	Class II	System INFX-8000C	Canon Medical Systems USA, Inc.	OWB	2021-02-05
Z-1174-2021	Class II	System INFX-8000V	Canon Medical Systems USA, Inc.	OWB	2021-02-05
Z-1183-2021	Class III	Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of...	OraSure Technologies, Inc.	LAF	2021-02-05
Z-1524-2021	Class II	DJO EMPOWR KNEE Femoral Sizer	Encore Medical, LP	JWH	2021-02-05
Z-1330-2021	Class II	Product Label - ACUSON Sequoia * Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *...	Siemens Medical Solutions USA, Inc.	IYN	2021-02-04
Z-1199-2021	Class I	Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1198-2021	Class I	Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1197-2021	Class I	Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1196-2021	Class I	Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1195-2021	Class I	Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1194-2021	Class I	Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1193-2021	Class I	Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1192-2021	Class I	Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1191-2021	Class I	Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1190-2021	Class I	Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with...	Medtronic Perfusion Systems	DTN	2021-02-04
Z-1312-2021	Class II	Coronavirus antigen detection test system - Product Usage: intended for the qualitative...	LumiraDx	QKP	2021-02-03