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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 277 of 1190

FDA device recalls, page 277 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2493-2021	Class II	General Manual surgical instrument	M.D.L. S.r.l.	MJG	2021-08-05
Z-2492-2021	Class II	Soft Tissue Biopsy Needles	M.D.L. S.r.l.	KNW	2021-08-05
Z-2491-2021	Class II	Mammary Nodules Localization	M.D.L. S.r.l.	GDF	2021-08-05
Z-2490-2021	Class II	Aspirated Cyto-Histological Biopsy needle	M.D.L. S.r.l.	GAA	2021-08-05
Z-2489-2021	Class II	Bone Marrow Transplantation biopsy needle	M.D.L. S.r.l.	DWO	2021-08-05
Z-2498-2021	Class II	cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number...	Roche Molecular Systems Inc	QLT	2021-08-04
Z-2576-2021	Class II	Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM...	Abbott Molecular, Inc.	OVQ	2021-08-04
Z-2469-2021	Class I	Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena...	Mac Medical Supply Co Inc	ITX	2021-08-04
Z-2401-2021	Class II	smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm...	Abbott Medical	OGK	2021-08-04
Z-2286-2021	Class I	Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125...	Medtronic, Inc.	NGT	2021-08-04
Z-2285-2021	Class I	Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code...	Medtronic, Inc.	NGT	2021-08-04
Z-2284-2021	Class I	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code...	Medtronic, Inc.	NGT	2021-08-04
Z-1364-2022	Class II	AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA...	Fresenius Medical Care Renal Therapies Group, LLC	FIP	2021-08-03
Z-2451-2021	Class II	Verigene EP Amplification Reagent Kit Test	Luminex Corporation	PCH	2021-08-03
Z-2423-2021	Class II	Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number...	OLYMPUS Corporation of the Americas	FED	2021-08-03
Z-2594-2021	Class II	uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare...	Shanghai United Imaging Healthcare Co., Ltd.	KPS	2021-08-02
Z-2593-2021	Class II	uMI 550 System - Product Usage: intended to be operated by qualified healthcare...	Shanghai United Imaging Healthcare Co., Ltd.	KPS	2021-08-02
Z-2468-2021	Class II	BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1...	CareFusion 303, Inc	FPA	2021-08-02
Z-2467-2021	Class II	BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite...	CareFusion 303, Inc	FPA	2021-08-02
Z-2466-2021	Class II	BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3...	CareFusion 303, Inc	FPA	2021-08-02
Z-2465-2021	Class II	BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006	CareFusion 303, Inc	FPA	2021-08-02
Z-2464-2021	Class II	BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006	CareFusion 303, Inc	FPA	2021-08-02
Z-2463-2021	Class II	BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF...	CareFusion 303, Inc	FPA	2021-08-02
Z-2462-2021	Class II	BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564	CareFusion 303, Inc	FPA	2021-08-02
Z-2596-2021	Class II	Flow sensors that may be installed in the following GEHC anesthesia machines: (1)...	GE Healthcare	BSZ	2021-08-02
Z-2595-2021	Class II	Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia...	GE Healthcare	BSZ	2021-08-02
Z-2393-2021	Class II	Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter...	Magnolia Medical Technologies, Inc.	JKA	2021-08-02
Z-2461-2021	Class II	BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE...	CareFusion 303, Inc	FPA	2021-08-02
Z-2460-2021	Class II	BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension...	CareFusion 303, Inc	FPA	2021-08-02
Z-2459-2021	Class II	BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port...	CareFusion 303, Inc	FPA	2021-08-02
Z-2458-2021	Class II	BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E	CareFusion 303, Inc	FPA	2021-08-02
Z-2457-2021	Class II	BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF...	CareFusion 303, Inc	FPA	2021-08-02
Z-2456-2021	Class II	BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV...	CareFusion 303, Inc	FPA	2021-08-02
Z-2455-2021	Class II	BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D	CareFusion 303, Inc	FPA	2021-08-02
Z-2454-2021	Class II	BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E	CareFusion 303, Inc	FPA	2021-08-02
Z-2488-2021	Class II	Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28...	Paragon 28	HTW	2021-07-30
Z-2347-2021	Class II	Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2346-2021	Class II	Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2345-2021	Class II	Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2344-2021	Class II	Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2343-2021	Class II	Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2342-2021	Class II	Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2341-2021	Class II	Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as...	Philips North America LLC	LNH	2021-07-30
Z-2481-2021	Class II	BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375	Leica Microsystems, Inc.	NJT	2021-07-30
Z-2470-2021	Class II	Arjo Disposable Repositioning Sling, Model AHD001	Arjo Dominican Republic	FSA	2021-07-30
Z-1573-2022	Class II	HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144	Mizuho Orthopedic Systems Inc	LXH	2021-07-29
Z-0033-2022	Class III	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product...	Sentinel CH SpA	JIS	2021-07-29
Z-2562-2021	Class II	LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702...	Lymol Medical Corporation	EOQ	2021-07-29
Z-2339-2021	Class II	OASIS MRI System	FUJIFILM Healthcare Americas Corporation	LNH	2021-07-29
Z-2338-2021	Class II	ECHELON Oval MRI System	FUJIFILM Healthcare Americas Corporation	LNH	2021-07-29