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 776 of 1190

FDA device recalls, page 776 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0656-2013	Class II	Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127...	Howmedica Osteonics Corp	MEH	2012-10-23
Z-0747-2013	Class III	Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere...	Alere San Diego, Inc.	JJY	2012-10-22
Z-0746-2013	Class III	Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere...	Alere San Diego, Inc.	JJY	2012-10-22
Z-0523-2013	Class II	BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty...	Becton Dickinson & Co	GRO	2012-10-22
Z-0288-2013	Class II	TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System...	Endologix LLC	MIH	2012-10-19
Z-0535-2013	Class II	Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton...	Titan Spine, LLC	MQP	2012-10-19
Z-0259-2013	Class II	AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System...	American Medical Systems, Inc.	FTL	2012-10-19
Z-0403-2013	Class II	qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm...	GE Healthcare	MHX	2012-10-19
Z-0428-2013	Class II	IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used...	Innovative Magnetic Resonance Imaging Systems, Inc.	LNH	2012-10-19
Z-0432-2013	Class II	4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension...	Orthopediatrics Corp	HRS	2012-10-18
Z-0466-2013	Class II	NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series...	Neusoft Medical Systems Co., Ltd.	JAK	2012-10-18
Z-0411-2013	Class II	PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO...	Gyrus ACMI, Inc.	ETD	2012-10-17
Z-0430-2013	Class II	0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated...	bioMerieux, Inc.		2012-10-17
Z-0329-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0328-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0327-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0326-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0325-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0324-2013	Class II	bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0323-2013	Class II	bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update...	bioMerieux, Inc.	MDB	2012-10-16
Z-0322-2013	Class II	bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0321-2013	Class II	bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0320-2013	Class II	bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The...	bioMerieux, Inc.	MDB	2012-10-16
Z-0319-2013	Class II	bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The...	bioMerieux, Inc.	MDB	2012-10-16
Z-0318-2013	Class II	bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The...	bioMerieux, Inc.	MDB	2012-10-16
Z-0317-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0316-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0315-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0314-2013	Class II	bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0313-2013	Class II	bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update...	bioMerieux, Inc.	MDB	2012-10-16
Z-0312-2013	Class II	bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and...	bioMerieux, Inc.	MDB	2012-10-16
Z-0311-2013	Class II	bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and...	bioMerieux, Inc.	MDB	2012-10-16
Z-0310-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0309-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0308-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0307-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0306-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0305-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0304-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0303-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0302-2013	Class II	bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software...	bioMerieux, Inc.	MDB	2012-10-16
Z-0301-2013	Class II	bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is...	bioMerieux, Inc.	MDB	2012-10-16
Z-0300-2013	Class II	bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The...	bioMerieux, Inc.	MDB	2012-10-16
Z-0330-2013	Class II	Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular...	Vital Signs, Inc.	HGP	2012-10-16
Z-0299-2013	Class II	bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The...	bioMerieux, Inc.	MDB	2012-10-16
Z-0279-2013	Class II	Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a...	Terumo Cardiovascular Systems Corporation	DWC	2012-10-16
Z-0278-2013	Class II	HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a...	Terumo Cardiovascular Systems Corporation	DWC	2012-10-16
Z-1097-2014	Class II	The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee...	Ossur Americas		2012-10-15
Z-1101-2013	Class II	MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI...	Canon Medical Systems USA, Inc.	LNH	2012-10-15
Z-0749-2013	Class I	Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System...	GE Healthcare	BTM	2012-10-15