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 304 of 1190

FDA device recalls, page 304 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1204-2021	Class II	CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	2021-01-15
Z-1148-2021	Class II	Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300...	Northgate Technologies Inc.	FCX	2021-01-15
Z-1147-2021	Class II	ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The...	Northgate Technologies Inc.	HIF	2021-01-15
Z-1156-2021	Class II	HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.)...	Hamilton Co	JQW	2021-01-15
Z-0941-2021	Class II	SARS-CoV-2 Antigen Test	Qiagen	QKP	2021-01-15
Z-1131-2021	Class II	Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for...	Zimmer GmbH	PHX	2021-01-15
Z-1135-2021	Class III	S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the...	MEDLINE INDUSTRIES, LP - Northfield	JJX	2021-01-15
Z-1289-2021	Class II	BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF...	Bard Peripheral Vascular Inc	KNW	2021-01-14
Z-1189-2021	Class II	PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is...	Physio Control, Inc.	MKJ	2021-01-14
Z-1136-2021	Class II	VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to...	Ortho-Clinical Diagnostics, Inc.	DIP	2021-01-14
Z-1184-2021	Class II	Power Injectable CT Port insertion kits - Product Usage: is an implantable access device...	Medical Components, Inc.	LJT	2021-01-13
Z-1146-2021	Class II	ENROUTE Transcarotid Stent System REF SR-XXYY-CS	Silk Road Medical	NIM	2021-01-13
Z-1142-2021	Class II	Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product...	Medtronic, Inc.	FTL	2021-01-13
Z-1105-2021	Class II	Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201...	BEMER Int. AG	NGX	2021-01-13
Z-2230-2021	Class II	Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226...	TeleMed Systems	OCZ	2021-01-12
Z-2229-2021	Class II	Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended...	TeleMed Systems	OCZ	2021-01-12
Z-1143-2021	Class II	Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for...	Natus Manufacturing Limited	JXG	2021-01-12
Z-1132-2021	Class II	LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute...	LumiraDx	QKP	2021-01-11
Z-1141-2021	Class II	Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage...	Microtek Medical LLC	PUI	2021-01-11
Z-1431-2021	Class II	Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological)...	C.R. Bard Inc	KOD	2021-01-11
Z-1117-2021	Class II	Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following...	Medtronic Neurosurgery	JXG	2021-01-11
Z-1116-2021	Class II	Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and...	Medtronic Neurosurgery	JXG	2021-01-11
Z-1115-2021	Class II	Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following...	Medtronic Neurosurgery	JXG	2021-01-11
Z-1162-2021	Class II	WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/...	Nihon Kohden America Inc	DRG	2021-01-08
Z-1103-2021	Class II	Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the...	Depuy Orthopaedics Inc.	JWH	2021-01-08
Z-1128-2021	Class II	13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in...	Cairn Diagnostics	PGE	2021-01-08
Z-0954-2021	Class II	BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro...	Becton Dickinson & Co	QJR	2021-01-07
Z-1151-2021	Class II	The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning...	Baxter Healthcare Corporation	KDI	2021-01-07
Z-1083-2021	Class II	ChemoPlus" Chemo Prep & Admin Kit, CT4025	Medtronic, Inc.	LYU	2021-01-07
Z-1082-2021	Class II	Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K	Medtronic, Inc.	LYU	2021-01-07
Z-1081-2021	Class II	ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K	Medtronic, Inc.	LYU	2021-01-07
Z-1080-2021	Class II	Chemoplus Drug Spill Kit Hos, Sku Ct4004	Medtronic, Inc.	LYU	2021-01-07
Z-1079-2021	Class II	CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large...	Medtronic, Inc.	LYU	2021-01-07
Z-1078-2021	Class II	Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K	Medtronic, Inc.	LYU	2021-01-07
Z-1097-2021	Class II	Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall"...	Medtronic, Inc.	OEA	2021-01-07
Z-1096-2021	Class II	Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1095-2021	Class II	Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall"...	Medtronic, Inc.	OEA	2021-01-07
Z-1094-2021	Class II	Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1093-2021	Class II	Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1092-2021	Class II	Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1091-2021	Class II	Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1090-2021	Class II	Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1089-2021	Class II	Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1088-2021	Class II	Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1087-2021	Class II	Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation...	Medtronic, Inc.	OEA	2021-01-07
Z-1086-2021	Class II	Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and...	Medtronic, Inc.	OEA	2021-01-07
Z-1085-2021	Class II	Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG...	Medtronic, Inc.	OEA	2021-01-07
Z-1137-2021	Class II	PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1...	Respironics, Inc.	MNT	2021-01-06
Z-1098-2021	Class II	9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of...	Roche Diagnostics GmbH	JFP	2021-01-06
Z-1106-2021	Class II	Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2021-01-06