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 600 of 1191

FDA device recalls, page 600 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1993-2016	Class II	LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part...	Physio Control, Inc.	MKJ	2016-01-27
Z-1238-2016	Class II	Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon...	Cook Incorporated	LJE	2016-01-27
Z-1237-2016	Class II	UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a...	Cook Incorporated	LJE	2016-01-27
Z-1025-2016	Class II	Karma Flexx Wheelchair Manual Wheelchair.	Karman Healthcare Inc	IOR	2016-01-27
Z-1497-2016	Class II	AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY...	Applied Medical Technology Inc	KNT	2016-01-26
Z-1194-2016	Class II	Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400	QiG Group LLC	LGW	2016-01-26
Z-1193-2016	Class II	Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)	QiG Group LLC	LGW	2016-01-26
Z-1192-2016	Class II	Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)	QiG Group LLC	LGW	2016-01-26
Z-1183-2016	Class II	Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers...	Siemens Medical Solutions USA, Inc.	LLZ	2016-01-25
Z-0813-2016	Class II	Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model...	LivaNova USA, Inc.	DWF	2016-01-25
Z-0851-2016	Class III	BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the...	Becton, Dickinson and Company, BD Biosciences	MVU	2016-01-25
Z-0771-2016	Class II	CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover...	Accuray Incorporated	IYE	2016-01-22
Z-1229-2016	Class II	Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1228-2016	Class II	Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1227-2016	Class II	Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are...	Medtronic, Inc.	EZL	2016-01-22
Z-1226-2016	Class II	Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile...	Medtronic, Inc.	EZL	2016-01-22
Z-1225-2016	Class II	Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1224-2016	Class II	Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1223-2016	Class II	Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are...	Medtronic, Inc.	EZL	2016-01-22
Z-1222-2016	Class II	Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1221-2016	Class II	Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1220-2016	Class II	Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1219-2016	Class II	Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1218-2016	Class II	Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP...	Medtronic, Inc.	EZL	2016-01-22
Z-1217-2016	Class II	Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1216-2016	Class II	Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1215-2016	Class II	Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1214-2016	Class II	Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile...	Medtronic, Inc.	EZL	2016-01-22
Z-1213-2016	Class II	Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1212-2016	Class II	Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1211-2016	Class II	Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1210-2016	Class II	Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1209-2016	Class II	Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are...	Medtronic, Inc.	EZL	2016-01-22
Z-1208-2016	Class II	Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1171-2016	Class II	Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro...	Sekisui Diagnostics P.E.I. Inc.	LDP	2016-01-22
Z-1207-2016	Class II	Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile...	Medtronic, Inc.	KOY	2016-01-22
Z-1206-2016	Class II	Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes...	Medtronic, Inc.	EZL	2016-01-22
Z-1205-2016	Class II	Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap...	Medtronic, Inc.	EZL	2016-01-22
Z-1204-2016	Class II	Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes...	Medtronic, Inc.	KOY	2016-01-22
Z-1203-2016	Class II	Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are...	Medtronic, Inc.	KOY	2016-01-22
Z-1202-2016	Class II	Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are...	Medtronic, Inc.	KOY	2016-01-22
Z-1201-2016	Class II	Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are...	Medtronic, Inc.	KOY	2016-01-22
Z-1200-2016	Class II	Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are...	Medtronic, Inc.	KOY	2016-01-22
Z-1199-2016	Class II	Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes...	Medtronic, Inc.	KOY	2016-01-22
Z-1198-2016	Class II	Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are...	Medtronic, Inc.	KOY	2016-01-22
Z-1197-2016	Class II	Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes...	Medtronic, Inc.	KOY	2016-01-22
Z-1196-2016	Class II	Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean...	Medtronic, Inc.	KOY	2016-01-22
Z-1563-2016	Class II	3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.	3M Company	FLF	2016-01-22
Z-0864-2016	Class II	EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main...	EKOS Corporation	KRA	2016-01-21
Z-0884-2016	Class II	Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary...	Howmedica Osteonics Corp	MAY	2016-01-21