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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 733 of 1191

FDA device recalls, page 733 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0525-2015	Class II	Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access...	Concentric Medical, Inc.	DQY	2013-09-26
Z-0276-2014	Class II	3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur...	Orthopediatrics Corp	HRS	2013-09-26
Z-0170-2014	Class II	HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz...	Hamilton Medical AG	CBK	2013-09-26
Z-0458-2014	Class II	Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo...	Ethicon, Inc	NEW	2013-09-25
Z-0392-2014	Class II	Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation...	Baxter Healthcare Corporation	LHI	2013-09-25
Z-0778-2014	Class II	Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12...	SPINEFRONTIER, Inc. dba LESspine Innovations	HTE	2013-09-24
Z-0777-2014	Class II	Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12...	SPINEFRONTIER, Inc. dba LESspine Innovations	HTE	2013-09-24
Z-0375-2014	Class II	Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque...	Howmedica Osteonics Corp	LXH	2013-09-24
Z-0411-2014	Class II	Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet...	Ebi, LLC	HXX	2013-09-24
Z-0341-2014	Class II	Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation...	Synthes GmbH	GAD	2013-09-24
Z-0142-2014	Class II	S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert...	LivaNova Deutschland GmbH	DTQ	2013-09-24
Z-0365-2014	Class II	Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2...	Siemens Healthcare Diagnostics Inc.	CIG	2013-09-24
Z-0189-2014	Class II	SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen...	Baxter Healthcare Corporation	FRN	2013-09-24
Z-0113-2014	Class II	COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a...	Siemens Healthcare Diagnostics Inc.	GKZ	2013-09-24
Z-0147-2014	Class II	UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600...	Siemens Healthcare Diagnostics Inc.	GKZ	2013-09-24
Z-0776-2014	Class II	Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the...	SPINEFRONTIER, Inc. dba LESspine Innovations	HTE	2013-09-24
Z-2045-2015	Class II	ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map...	Volcano Corporation	IYO	2013-09-23
Z-2044-2015	Class II	Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure...	Volcano Corporation	IYO	2013-09-23
Z-2043-2015	Class II	Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System...	Volcano Corporation	IYO	2013-09-23
Z-0053-2014	Class III	Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control...	Alere San Diego, Inc.	DIF	2013-09-23
Z-0085-2014	Class I	Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic...	Baylis Medical Co., Inc.	DYB	2013-09-23
Z-0376-2014	Class II	ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for...	Ivoclar Vivadent, Inc.	MZW	2013-09-23
Z-0164-2014	Class II	Portex Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family...	Abbott Medical	CAZ	2013-09-23
Z-0163-2014	Class II	Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The...	Abbott Medical	CAZ	2013-09-23
Z-0162-2014	Class II	Portex Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family...	Abbott Medical	CAZ	2013-09-23
Z-0161-2014	Class II	Portex Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of...	Abbott Medical	CAZ	2013-09-23
Z-0160-2014	Class II	Portex Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of...	Abbott Medical	CAZ	2013-09-23
Z-0159-2014	Class II	Portex Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of...	Abbott Medical	CAZ	2013-09-23
Z-0158-2014	Class II	Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of...	Abbott Medical	CAZ	2013-09-23
Z-0157-2014	Class II	Portex Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family...	Abbott Medical	CAZ	2013-09-23
Z-0156-2014	Class II	Portex Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional...	Abbott Medical	CAZ	2013-09-23
Z-1686-2015	Class II	MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the...	Medrad, Inc.	DXT	2013-09-20
Z-2566-2014	Class II	Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part#...	Biomet Microfixation	LZD	2013-09-20
Z-0651-2014	Class II	The Vantage Digital Panoramic System delivers high-value features standard on every...	Midmark Corp dba Progeny Inc	MUH	2013-09-20
Z-0361-2014	Class II	Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)	Aesculap Inc	LXH	2013-09-20
Z-0001-2014	Class II	Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during...	Maquet Cardiovascular LLC	OFA	2013-09-20
Z-0472-2014	Class I	Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package...	GE Healthcare	BSF	2013-09-19
Z-0270-2014	Class II	AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH...	GE Healthcare	LLZ	2013-09-19
Z-0492-2014	Class II	Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7	Aesculap Inc	JWH	2013-09-19
Z-0042-2014	Class I	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test...	Atossa Genetics, Inc.	KNW	2013-09-19
Z-0035-2014	Class II	IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and...	AGFA Healthcare Corp.	LLZ	2013-09-19
Z-0145-2014	Class II	Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization...	Richard Wolf Medical Instruments Corp.	FJL	2013-09-18
Z-0541-2014	Class II	Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in...	Siemens Healthcare Diagnostics Inc.	LPS	2013-09-18
Z-0066-2014	Class II	GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC...	GE Hangwei Medical Systems, Co. Ltd	OXO	2013-09-18
Z-0043-2014	Class II	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double...	Advanced Sterilization Products	MLR	2013-09-18
Z-0044-2014	Class II	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general...	Advanced Sterilization Products	MLR	2013-09-18
Z-0839-2014	Class II	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS...	DeRoyal Industries, Inc.	ILO	2013-09-17
Z-0838-2014	Class II	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF...	DeRoyal Industries, Inc.	ILO	2013-09-17
Z-0837-2014	Class II	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF...	DeRoyal Industries, Inc.	ILO	2013-09-17
Z-0836-2014	Class II	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS...	DeRoyal Industries, Inc.	ILO	2013-09-17