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 661 of 1191

FDA device recalls, page 661 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2226-2015	Class II	Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	FCP	2015-02-11
Z-2225-2015	Class II	Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	GEI	2015-02-11
Z-2224-2015	Class II	Medical Device Exchange - Auto Suture Endo Universal 65 4mm; Pouch, Tyvek/Mylar...	EXP Pharmaceutical Services Corp	GCY	2015-02-11
Z-2223-2015	Class II	Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	GCY	2015-02-11
Z-2222-2015	Class II	Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	HBL	2015-02-11
Z-2221-2015	Class II	Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2220-2015	Class II	Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2219-2015	Class II	Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch...	EXP Pharmaceutical Services Corp	GCW	2015-02-11
Z-2218-2015	Class II	Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2217-2015	Class II	Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm...	EXP Pharmaceutical Services Corp	GCW	2015-02-11
Z-2216-2015	Class II	Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use...	EXP Pharmaceutical Services Corp	GCI	2015-02-11
Z-2215-2015	Class II	Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2214-2015	Class II	Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch...	EXP Pharmaceutical Services Corp	MBI	2015-02-11
Z-2213-2015	Class II	Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2212-2015	Class II	Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile...	EXP Pharmaceutical Services Corp	GCJ	2015-02-11
Z-2211-2015	Class II	Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single...	EXP Pharmaceutical Services Corp	FYA	2015-02-11
Z-1952-2015	Class III	Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue...	Milestone Scientific, Inc.	EJI	2015-02-11
Z-1399-2015	Class II	ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2...	Siemens Healthcare Diagnostics Inc.	JGS	2015-02-11
Z-1291-2015	Class II	Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr...	Sybron Dental Specialties, Inc.	MMP	2015-02-11
Z-1246-2015	Class II	SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate...	Depuy Orthopaedics Inc.	MBB	2015-02-11
Z-1142-2015	Class II	EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci...	Intuitive Surgical, Inc.	NAY	2015-02-11
Z-1141-2015	Class II	EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci...	Intuitive Surgical, Inc.	NAY	2015-02-11
Z-2066-2015	Class III	G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin...	Tosoh Bioscience Inc	LCP	2015-02-10
Z-1808-2015	Class II	T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12...	Aquabiliti	NGT	2015-02-09
Z-1555-2015	Class II	Philips Healthcare DuraDiagnost X- Ray	Philips North America LLC	KPR	2015-02-09
Z-1554-2015	Class II	Philips Healthcare DigitalDiagnost System X-Ray	Philips North America LLC	MQB	2015-02-09
Z-1239-2015	Class II	CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02	CooperSurgical, Inc.	HHW	2015-02-09
Z-1267-2015	Class II	SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0...	Siemens Medical Solutions USA, Inc.	JAK	2015-02-06
Z-1116-2015	Class II	Terumo HX2 Temperature Management System provides temperature control of two independent...	Terumo Cardiovascular Systems Corporation	DWC	2015-02-06
Z-2259-2015	Class II	Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce...	Philips North America LLC	JAK	2015-02-05
Z-2258-2015	Class II	Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce...	Philips North America LLC	JAK	2015-02-05
Z-2257-2015	Class II	Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional...	Philips North America LLC	JAK	2015-02-05
Z-2256-2015	Class II	Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional...	Philips North America LLC	JAK	2015-02-05
Z-2255-2015	Class II	Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to...	Philips North America LLC	JAK	2015-02-05
Z-2740-2015	Class II	DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for...	Derma Pen, LLC	PIU	2015-02-05
Z-2254-2015	Class II	Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence...	Philips North America LLC	JAK	2015-02-05
Z-1359-2015	Class II	Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology...	Philips North America LLC	JAK	2015-02-05
Z-1219-2015	Class II	Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis...	Zimmer GmbH	LZO	2015-02-05
Z-1351-2015	Class II	Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion...	Medical Components, Inc.	MSD	2015-02-05
Z-1232-2015	Class II	Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials...	Remel Inc	JSK	2015-02-05
Z-1236-2015	Class II	Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only...	Zipline Medical, Inc.	KGX	2015-02-05
Z-1235-2015	Class II	Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx...	Zipline Medical, Inc.	KGX	2015-02-05
Z-1234-2015	Class II	Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number...	Zipline Medical, Inc.	KGX	2015-02-05
Z-1233-2015	Class II	ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DSP	2015-02-05
Z-1611-2015	Class II	FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and...	FUJIFILM Healthcare Americas Corporation	DQK	2015-02-04
Z-1612-2015	Class II	Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular...	FUJIFILM Healthcare Americas Corporation	DQK	2015-02-04
Z-1287-2015	Class II	Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical...	Materialise N.V.	JWH	2015-02-04
Z-1325-2015	Class II	NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D...	Zimmer Trabecular Metal Technology, Inc.	MBH	2015-02-04
Z-2785-2016	Class II	GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap	Allergy Laboratories, Inc.	LDH	2015-02-03
Z-0354-2016	Class II	Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura...	Philips North America LLC	OWB	2015-02-03