510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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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 , the FDA export date. FDA medical device recall database

59,460 records, page 73 of 1190
FDA device recalls, page 73 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2356-2025Class IIIC6-3 Transducer ProbePhilips North America LLCIYN
Z-2355-2025Class IIIC6-2 Transducer ProbePhilips North America LLCIYN
Z-2354-2025Class IIIC5-2 Lumify Transducer ProbePhilips North America LLCIYN
Z-2353-2025Class IIIC5-2 Transducer ProbePhilips North America LLCIYN
Z-2352-2025Class IIIc5-1 Transducer ProbePhilips North America LLCIYN
Z-2351-2025Class IIIC10-4ec Transducer ProbePhilips North America LLCIYN
Z-2350-2025Class IIIC10-3v Transducer ProbePhilips North America LLCIYN
Z-2349-2025Class IIIBP10-5ec Transducer ProbePhilips North America LLCIYN
Z-2348-2025Class III7.5MHZ Endo Transducer ProbePhilips North America LLCITX
Z-2443-2025Class IIOrascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens...Orascoptic Surgical AcuityEBA
Z-2442-2025Class IIOrascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens...Orascoptic Surgical AcuityEBA
Z-2347-2025Class III3D9-3v Transducer ProbePhilips North America LLCIYN
Z-2621-2025Class IIt:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)Tandem Diabetes Care, Inc.QFG
Z-2441-2025Class IIOrascoptic Superior Visualization Custom loupes configured with Phantom FramesOrascoptic Surgical AcuityEBA
Z-2440-2025Class IIOrascoptic Superior Visualization Custom loupes with Dragonfly framesOrascoptic Surgical AcuityFSP
Z-2346-2025Class III3D6-2 Transducer ProbePhilips North America LLCIYN
Z-2342-2025Class IIGE HealthCare OEC 9900 Elite C-arm Systems.GE HealthcareOWB
Z-2341-2025Class IIGE HealthCare OEC 9800.GE HealthcareOWB
Z-2287-2025Class IISparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K...Spark Biomedical Inc.PZR
Z-2277-2025Class IIStryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK...Stryker Corp.KCY
Z-2637-2025Class IIJUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT...North American Rescue LLC.DXC
Z-2284-2025Class IIBrand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll...Carefree Surgical Specialties, Inc.GDY
Z-2283-2025Class IIBrand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls...Carefree Surgical Specialties, Inc.GDY
Z-2282-2025Class IIBrand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls...Carefree Surgical Specialties, Inc.GDY
Z-2281-2025Class IIBrand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner +...Carefree Surgical Specialties, Inc.GDY
Z-2280-2025Class IIBrand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL...Spineart SANKB
Z-2279-2025Class IIBrand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL...Spineart SANKB
Z-2229-2025Class IDreamStation Auto. Non-Continuous Ventilator.Respironics, Inc.BZD
Z-2228-2025Class IDreamStation Auto BiPAP. Non-Continuous Ventilator.Respironics, Inc.BZD
Z-2227-2025Class IDreamStation Auto CPAP. Non-Continuous Ventilator.Respironics, Inc.BZD
Z-2218-2025Class IIUpgrade to MR 7700 Model Number (REF): 782130;Philips North America LLCLNH
Z-2217-2025Class IISmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;Philips North America LLCLNH
Z-2216-2025Class IISmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3)...Philips North America LLCLNH
Z-2215-2025Class IISmartPath to dStream for 3.0T Model Number (REF): 782145;Philips North America LLCLNH
Z-2214-2025Class IIMR 7700 Model Numbers (REF): (1) 782120, (2) 782153;Philips North America LLCLNH
Z-2213-2025Class IIMR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;Philips North America LLCLNH
Z-2212-2025Class IIIntera 3.0T Quasar Dual Model Number (REF): 781150;Philips North America LLCLNH
Z-2211-2025Class IIIngenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136...Philips North America LLCLNH
Z-2210-2025Class IIIngenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150...Philips North America LLCLNH
Z-2209-2025Class IIIngenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;Philips North America LLCLNH
Z-2208-2025Class IIIngenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY)...Philips North America LLCLNH
Z-2207-2025Class IIIngenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;Philips North America LLCLNH
Z-2206-2025Class IIIngenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;Philips North America LLCLNH
Z-2205-2025Class IIIngenia 1.5T S Model Number (REF): 781347;Philips North America LLCLNH
Z-2204-2025Class IIIngenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5)...Philips North America LLCLNH
Z-2203-2025Class IIEvolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;Philips North America LLCLNH
Z-2202-2025Class IIEvolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;Philips North America LLCLNH
Z-2201-2025Class IIAchieva XR; Model Numbers (REF): (1) 781153, (2) 781253;Philips North America LLCLNH
Z-2200-2025Class IIAchieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5)...Philips North America LLCLNH
Z-2113-2025Class IILaser light show projectors manufactured by BLS, Model PURE 5000/10000.Beyond Laser Systems, LLCREA