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 99 of 1190
FDA device recalls, page 99 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1024-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Boston Scientific CorporationKNS
Z-1018-2025Class IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on...Randox Laboratories, LimitedDFC
Z-1017-2025Class IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay...Randox Laboratories, LimitedDFC
Z-1011-2025Class IIBaxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519Baxter Healthcare CorporationFPA
Z-1010-2025Class IIBaxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538Baxter Healthcare CorporationFPA
Z-1009-2025Class IIBaxter Solution Set with Duo-Vent Spike, REF 2R8404Baxter Healthcare CorporationFPA
Z-0887-2025Class IBreathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APBaxter Healthcare CorporationCBK
Z-0886-2025Class IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APBaxter Healthcare CorporationCBK
Z-0885-2025Class IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002ABaxter Healthcare CorporationCBK
Z-0884-2025Class IWelch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002Baxter Healthcare CorporationCBK
Z-1104-2025Class IIIntegra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item...New Medical Technologies GmbHGEH
Z-1064-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123Karl Storz Endoscopy-America, Inc.FGB
Z-0883-2025Class II8Mm,force Bipolar,is4000 Ref 471405Intuitive Surgical, Inc.NAY
Z-0882-2025Class II8Mm,long Bipolar Grasper,is4000 Ref 471400Intuitive Surgical, Inc.NAY
Z-0881-2025Class II8Mm,curved Bipolar Dissector,is4000 Ref 471344Intuitive Surgical, Inc.NAY
Z-0880-2025Class II8Mm,mega Suturecut Nd,is4000 Ref 471309Intuitive Surgical, Inc.NAY
Z-0879-2025Class II8Mm,large Suturecut Needle Driver,is4000 Ref 471296Intuitive Surgical, Inc.NAY
Z-0878-2025Class II8Mm,fenestrated Bipolar Forceps,is4000 Ref 471205Intuitive Surgical, Inc.NAY
Z-0877-2025Class II8Mm,cobra Grasper,is4000 Ref 471190Intuitive Surgical, Inc.NAY
Z-0876-2025Class II8Mm,maryland Bipolar Forceps,is4000 Ref 471172Intuitive Surgical, Inc.NAY
Z-0875-2025Class II8Mm,micro Bipolar Forceps,is4000 Ref 471171Intuitive Surgical, Inc.NAY
Z-0874-2025Class II8Mm,prograsp Forceps,is4000 Ref 471093Intuitive Surgical, Inc.NAY
Z-0873-2025Class II8Mm,cadiere Forceps,is4000 Ref 471049Intuitive Surgical, Inc.NAY
Z-0872-2025Class II8Mm,long Tip Forceps,is4000 Ref 471048Intuitive Surgical, Inc.NAY
Z-0871-2025Class II8Mm,force Bipolar,is4000 Ref 470405Intuitive Surgical, Inc.NAY
Z-0870-2025Class II8Mm,horizon Small Clip Applier,is4000 Ref 470401Intuitive Surgical, Inc.NAY
Z-0869-2025Class II8Mm,tip-Up Fenestrated Grasper,is4000 Ref 470347Intuitive Surgical, Inc.NAY
Z-0868-2025Class II8Mm,curved Bipolar Dissector,is4000 Ref 470344Intuitive Surgical, Inc.NAY
Z-0867-2025Class II8Mm,medium-Large Clip Applier,is4000 Ref 470327Intuitive Surgical, Inc.NAY
Z-0866-2025Class II8Mm,small Grasping Retractor,is4000 Ref 470318Intuitive Surgical, Inc.NAY
Z-0865-2025Class II8Mm,mega Suturecut Nd,is4000 Ref 470309Intuitive Surgical, Inc.NAY
Z-0864-2025Class II8Mm,large Suturecut Needle Driver,is4000 Ref 470296Intuitive Surgical, Inc.NAY
Z-0863-2025Class II8Mm,dual Blade Retractor,is4000 Ref 470249Intuitive Surgical, Inc.NAY
Z-0862-2025Class II8Mm,atrial Retractor Short Right,is4000 Ref 470246Intuitive Surgical, Inc.NAY
Z-0861-2025Class II8Mm,large Hem-O-Lok Clip Applier,is4000 Ref 470230Intuitive Surgical, Inc.NAY
Z-0860-2025Class II8Mm,tenaculum Forceps,is4000 Ref 470207Intuitive Surgical, Inc.NAY
Z-0859-2025Class II8Mm,fenestrated Bipolar Forceps,is4000 Ref 470205Intuitive Surgical, Inc.NAY
Z-0858-2025Class II8Mm,mega Needle Driver,is4000 Ref 470194Intuitive Surgical, Inc.NAY
Z-0857-2025Class II8Mm,resano Forceps,is4000 Ref 470181Intuitive Surgical, Inc.NAY
Z-0856-2025Class II8Mm,maryland Bipolar Forceps,is4000 Ref 470172Intuitive Surgical, Inc.NAY
Z-0855-2025Class II8Mm,micro Bipolar Forceps,is4000 Ref 470171Intuitive Surgical, Inc.NAY
Z-0854-2025Class II8Mm,prograsp Forceps,is4000 Ref 470093Intuitive Surgical, Inc.NAY
Z-0853-2025Class II8Mm,cadiere Forceps,is4000 Ref 470049Intuitive Surgical, Inc.NAY
Z-0852-2025Class II8Mm,debakey Forceps,is4000 Ref 470036Intuitive Surgical, Inc.NAY
Z-0851-2025Class II8Mm,black Diamond Micro Forceps,is4000 Ref 470033Intuitive Surgical, Inc.NAY
Z-0850-2025Class II8Mm, Round Tip Scissors, Is4000 Ref 470007Intuitive Surgical, Inc.NAY
Z-0849-2025Class II8Mm, Large Needle Driver, Is4000 Ref 470006Intuitive Surgical, Inc.NAY
Z-0848-2025Class II8Mm, Potts Scissors, Is4000 Ref 470001Intuitive Surgical, Inc.NAY
Z-1103-2025Class IIIntegra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item...New Medical Technologies GmbHGEH
Z-1007-2025Class IIBrand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog...Ortho-Clinical Diagnostics, Inc.JJE