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 126 of 1190
FDA device recalls, page 126 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2785-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2784-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2783-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2782-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2781-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-3131-2024Class IINEUROSIGN Disposable Stimulating Dissector, REF 5888-00Technomed EuropeETN
Z-2688-2024Class IIBarricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-AIntrinsic Therapeutics, Inc.LXH
Z-2690-2024Class IVivo 45 LS, pressure and volume ventilator capable of delivering continuous or...Breas Medical ABNOU
Z-3302-2024Class II(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch...Medtronic, Inc.FEG
Z-3159-2024Class IIregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009ROi CPS LLCOEQ
Z-3301-2024Class II(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122...Medtronic, Inc.KNT
Z-3264-2024Class IIStryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components...TMJ Solutions, LLCLZD
Z-2734-2024Class IICARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570Schiller, AGDPS
Z-2692-2024Class IFreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous...Abbott MedicalQLG
Z-2940-2024Class IIMcKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C...Cypress Medical Products LLCFMF
Z-2731-2024Class IIStryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the...Stryker Corp.HBE
Z-2730-2024Class IIStryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the...Stryker Corp.HBE
Z-2729-2024Class IIStryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the...Stryker Corp.HBE
Z-2728-2024Class IIStryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the...Stryker Corp.HBE
Z-2727-2024Class IIStryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the...Stryker Corp.HBE
Z-2726-2024Class IIStryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following...Stryker Corp.HBE
Z-2725-2024Class IIStryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following...Stryker Corp.HBE
Z-2724-2024Class IIStryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following...Stryker Corp.HBE
Z-2723-2024Class IIStryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following...Stryker Corp.HBE
Z-2722-2024Class IIStryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following...Stryker Corp.HBE
Z-3160-2024Class IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a)...GE HealthcareLLZ
Z-3225-2024Class IIKarl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3224-2024Class IIKarl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3223-2024Class IIKarl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3186-2024Class IIVariSoft Infusion Set, Single Use.Unomedical A/SFPA
Z-3222-2024Class IIKarl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3221-2024Class IIKarl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3220-2024Class IIKarl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3219-2024Class IIKarl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-3218-2024Class IIKarl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123Karl Storz Endoscopy-America, Inc.FGA
Z-2952-2024Class IIDesflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the...Datascope Corp.BSZ
Z-2951-2024Class IIIsoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to...Datascope Corp.BSZ
Z-2950-2024Class IISevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to...Datascope Corp.BSZ
Z-2949-2024Class IISevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor...Datascope Corp.BSZ
Z-2416-2024Class IISlideView VS200 slide viewer,Evident Scientific IncRIB
Z-2587-2024Class IClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever...Inari Medical, Inc.QEW
Z-2616-2024Class IIBioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote...Biointellisense Inc.DRG
Z-0147-2025Class IIsmiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF...Abbott MedicalBYD
Z-0146-2025Class IIsmiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000Abbott MedicalBYD
Z-3151-2024Class IIVTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to...Boston Scientific CorporationFFA
Z-3150-2024Class IIvanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number...Boston Scientific CorporationFFA
Z-3149-2024Class IIFlexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To...Boston Scientific CorporationFFA
Z-3148-2024Class IIFlexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile...Boston Scientific CorporationFFA
Z-3147-2024Class IIFlexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b)...Boston Scientific CorporationFFA
Z-0145-2025Class IIsmiths medical portex, Y' PIECE 15MM, REF 100/276/000Abbott MedicalBYD