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 660 of 1191

FDA device recalls, page 660 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1324-2015	Class II	Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan...	Titan Spine, LLC	OVE	2015-02-20
Z-1561-2015	Class II	AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer...	STERIS Corporation	FLE	2015-02-19
Z-1559-2015	Class II	Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood...	STERIS Corporation	MDZ	2015-02-19
Z-1596-2015	Class III	ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a...	Arc Medical, Inc.	BYD	2015-02-19
Z-1317-2015	Class II	BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100...	Becton Dickinson & Co	FPA	2015-02-19
Z-1264-2015	Class III	Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1...	Richard-Allan Scientific LLC	HZJ	2015-02-19
Z-1176-2016	Class II	The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to...	CHG Hospital Beds Inc	FNL	2015-02-18
Z-1354-2015	Class II	Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display...	Siemens Medical Solutions USA, Inc.	LLZ	2015-02-18
Z-1943-2015	Class II	Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy...	United States Endoscopy Group, Inc.	OCX	2015-02-17
Z-1460-2015	Class II	EOS, Digital radiography system used in general radiographic examinations.	EOS imaging	MQB	2015-02-17
Z-1361-2015	Class II	Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part...	King Systems Corporation.	BZA	2015-02-17
Z-1295-2015	Class II	Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis...	Transonic Systems Inc	MQS	2015-02-17
Z-1281-2015	Class II	Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX...	Synthes GmbH	FZX	2015-02-17
Z-1316-2015	Class II	ExacTrac versions 6.x patient positioning systems are used to position patients during...	Brainlab, Inc.	IYE	2015-02-16
Z-1314-2015	Class II	Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x...	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HWC	2015-02-16
Z-1285-2015	Class II	GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers...	GE Healthcare	IOL	2015-02-16
Z-1226-2015	Class II	Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si...	Intuitive Surgical, Inc.	NAY	2015-02-16
Z-1459-2015	Class II	Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder...	Exactech, Inc.	KWS	2015-02-13
Z-1309-2015	Class II	Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5...	Aaren Scientific Inc.	HQL	2015-02-13
Z-1262-2015	Class II	- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral...	Medela AG	FMF	2015-02-13
Z-1327-2015	Class II	Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging...	Ameda, Inc.	HGY	2015-02-12
Z-1326-2015	Class II	Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek...	Ameda, Inc.	HGY	2015-02-12
Z-1261-2015	Class II	Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer...	Agilent Technologies, Inc.	KPA	2015-02-12
Z-1283-2015	Class II	Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture...	Howmedica Osteonics Corp	MBH	2015-02-12
Z-2252-2015	Class II	Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	JCT	2015-02-11
Z-2251-2015	Class II	Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar...	EXP Pharmaceutical Services Corp	LIT	2015-02-11
Z-2250-2015	Class II	Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch...	EXP Pharmaceutical Services Corp	MGB	2015-02-11
Z-2249-2015	Class II	Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	JCT	2015-02-11
Z-2248-2015	Class II	Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	JCT	2015-02-11
Z-2247-2015	Class II	Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch...	EXP Pharmaceutical Services Corp	GFF	2015-02-11
Z-2246-2015	Class II	Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	JDQ	2015-02-11
Z-2245-2015	Class II	Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch...	EXP Pharmaceutical Services Corp	GCA	2015-02-11
Z-2244-2015	Class II	Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch...	EXP Pharmaceutical Services Corp	GDW	2015-02-11
Z-2243-2015	Class II	Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch...	EXP Pharmaceutical Services Corp	FTL	2015-02-11
Z-2242-2015	Class II	Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch...	EXP Pharmaceutical Services Corp	FTL	2015-02-11
Z-2241-2015	Class II	Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	HBE	2015-02-11
Z-2240-2015	Class II	Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	HBE	2015-02-11
Z-2239-2015	Class II	Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar...	EXP Pharmaceutical Services Corp	HBE	2015-02-11
Z-2238-2015	Class II	Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	HBE	2015-02-11
Z-2237-2015	Class II	Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	GAO	2015-02-11
Z-2236-2015	Class II	Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM...	EXP Pharmaceutical Services Corp	HWE	2015-02-11
Z-2235-2015	Class II	Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM...	EXP Pharmaceutical Services Corp	DQX	2015-02-11
Z-2234-2015	Class II	Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM...	EXP Pharmaceutical Services Corp	MLV	2015-02-11
Z-2233-2015	Class II	Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM...	EXP Pharmaceutical Services Corp	MLV	2015-02-11
Z-2232-2015	Class II	Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	HIF	2015-02-11
Z-2231-2015	Class II	Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	FQH	2015-02-11
Z-2230-2015	Class II	Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	GEI	2015-02-11
Z-2229-2015	Class II	Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM...	EXP Pharmaceutical Services Corp	GDW	2015-02-11
Z-2228-2015	Class II	Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	GDI	2015-02-11
Z-2227-2015	Class II	Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	GDW	2015-02-11