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 807 of 1190

FDA device recalls, page 807 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1068-2012		AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow...	Angiodynamics Worldwide Headquarters	LJS	2012-02-06
Z-1114-2012		AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System...	Angiodynamics Worldwide Headquarters	KRA	2012-02-06
Z-1113-2012		AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System...	Angiodynamics Worldwide Headquarters	KRA	2012-02-06
Z-1112-2012		AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System...	Angiodynamics Worldwide Headquarters	KRA	2012-02-06
Z-1037-2012		Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System...	Orthofix SRL	max	2012-02-06
Z-0209-2014	Class II	*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use...	Abbott Medical	FRN	2012-02-05
Z-0208-2014	Class II	Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion...	Abbott Medical	FRN	2012-02-05
Z-0207-2014	Class II	Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion...	Abbott Medical	FRN	2012-02-05
Z-0206-2014	Class II	Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+...	Abbott Medical	FRN	2012-02-05
Z-0205-2014	Class II	Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion...	Abbott Medical	FRN	2012-02-05
Z-0204-2014	Class II	Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion...	Abbott Medical	FRN	2012-02-05
Z-0203-2014	Class II	Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+...	Abbott Medical	FRN	2012-02-05
Z-0122-2013	Class II	"**ORTHO SENSOR12-123-A Knee Trial for Trithion***1560 Saw grass Corporate...	Orthosensor, Inc.	ONN	2012-02-04
Z-1656-2012		ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136...	Gentherm Medical, LLC	DWJ	2012-02-03
Z-1033-2012		Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single...	Ventus Medical, Inc.	OHP	2012-02-03
Z-1132-2012		Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air...	Hill-Rom Inc.	INX	2012-02-03
Z-1131-2012		Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized...	Hill-Rom Inc.	INX	2012-02-03
Z-1382-2012		CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary...	Terumo Cardiovascular Systems Corporation	DRY	2012-02-03
Z-1381-2012		CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary...	Terumo Cardiovascular Systems Corporation	DRY	2012-02-03
Z-1380-2012		CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during...	Terumo Cardiovascular Systems Corporation	DRY	2012-02-03
Z-1379-2012		CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during...	Terumo Cardiovascular Systems Corporation	DRY	2012-02-03
Z-1378-2012		CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during...	Terumo Cardiovascular Systems Corporation	DRY	2012-02-03
Z-1316-2012		VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a...	Ortho-Clinical Diagnostics, Inc.	LBS	2012-02-02
Z-1099-2012		Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775...	Clarity Medical Systems	HKI	2012-02-02
Z-1277-2012		VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol]...	Ortho-Clinical Diagnostics, Inc.	JIX	2012-02-02
Z-1183-2012		SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately...	Sonitus Medical, Inc.	LXB	2012-02-02
Z-1182-2012		SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately...	Sonitus Medical, Inc.	LXB	2012-02-02
Z-1181-2012		SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately...	Sonitus Medical, Inc.	LXB	2012-02-02
Z-1180-2012		SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately...	Sonitus Medical, Inc.	LXB	2012-02-02
Z-1179-2012		SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately...	Sonitus Medical, Inc.	LXB	2012-02-02
Z-2209-2012	Class II	COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube...	Roche Molecular Systems Inc	JJF	2012-02-01
Z-2171-2012	Class II	i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro...	Abbott Medical	MYT	2012-02-01
Z-2170-2012	Class II	i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro...	Abbott Medical	NBC	2012-02-01
Z-2169-2012	Class II	i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro...	Abbott Medical	MMI	2012-02-01
Z-2013-2012	Class II	Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code...	Abbott Molecular, Inc.	JQW	2012-01-31
Z-1126-2012		Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard...	Medisystems Corp.	FIE	2012-01-31
Z-1040-2012		S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered...	Cordis US Corp.	NIO	2012-01-31
Z-1039-2012		S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent...	Cordis US Corp.	FGE	2012-01-31
Z-1213-2012		SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary...	Idev Technologies, Inc.	FGE	2012-01-31
Z-1218-2012		Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for...	Roche Diagnostics GmbH	JJE	2012-01-31
Z-1161-2012		Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model...	Varian Medical Systems, Inc.	MUJ	2012-01-30
Z-1175-2012		TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical...	Varian Medical Systems, Inc.	IYE	2012-01-30
Z-1217-2012		FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA...	Varian Medical Systems, Inc.	IYE	2012-01-30
Z-1384-2012		SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The...	Sendx Medical, Inc.	CHL	2012-01-30
Z-1322-2012		BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600...	Becton Dickinson & Co	MDB	2012-01-30
Z-1377-2012		Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2...	FUJIFILM Healthcare Americas Corporation	DFC	2012-01-30
Z-1095-2012		Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G...	Acclarent Inc	KTI	2012-01-30
Z-0003-2013	Class II	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE...	Siemens Healthcare Diagnostics Inc.	DHR	2012-01-27
Z-1171-2012		Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System...	DePuy Mitek, Inc.	MAI	2012-01-27
Z-1170-2012		Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is...	DePuy Mitek, Inc.	MAI	2012-01-27