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

59,336 records, page 27 of 1187
FDA device recalls, page 27 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2456-2026Class IITrigen Proximal Straight Humeral Nail 8/7 X 16, Ref: 71760816Smith & Nephew, Inc.HSB
Z-1824-2026Class IICENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050FMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1922-2026Class IIAccess Total T4 Calibrator, Catalog No. 33805Siemens Healthcare Diagnostics Inc.KLI
Z-1926-2026Class IIFlamingo Funnel Large, Model Number SQ20012-03SurgiSmoke SolutionsFYD
Z-1925-2026Class IIFlamingo Funnel Medium, Model Number SQ20012-02SurgiSmoke SolutionsFYD
Z-1924-2026Class IIFlamingo Funnel Small, Model Number SQ20012-01SurgiSmoke SolutionsFYD
Z-1979-2026Class IHalyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1978-2026Class IHalyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1977-2026Class IHalyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-1976-2026Class IHalyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-1975-2026Class IHalyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-1974-2026Class IHalyard CATH LAB kit. Model Number: SACL75-01.Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-1973-2026Class IHalyard CATH LAB kit. Model Number: SACL75AM.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1972-2026Class IHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1971-2026Class IHalyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1970-2026Class IHalyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1895-2026Class IILeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is...Magellan Diagnostics, Inc.DOF
Z-1894-2026Class IILeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is...Magellan Diagnostics, Inc.DOF
Z-1893-2026Class II(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit...Magellan Diagnostics, Inc.DOF
Z-1814-2026Class IIARTIS Pheno VE30A and VE40A, Model 10849000Siemens Medical Solutions USA, Inc.OWB
Z-1943-2026Class IIMesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styleHealthmark Industries Co., Inc.OCU
Z-1810-2026Class IILinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.LinkBio Corp.QHE
Z-1797-2026Class IOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Insulet CorporationQFG
Z-1795-2026Class IIB.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for...B.R.A.H.M.S GmbHQWH
Z-1804-2026Class IIStryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single...Stryker Sustainability SolutionsKCY
Z-1996-2026Class IIiLet Bionic Pancreas, REF: BB1001Beta Bionics, Inc.QFG
Z-1921-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AWindstone Medical Packaging, Inc.KDD
Z-1920-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994Windstone Medical Packaging, Inc.KDD
Z-1919-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14433Windstone Medical Packaging, Inc.KDD
Z-1948-2026Class IIMedtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac...Medtronic, Inc.OAD
Z-1917-2026Class IIArrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr...Arrow International LLC (subsidiary of Teleflex Incorporated)OFC
Z-1916-2026Class IIMAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF...Arrow International LLC (subsidiary of Teleflex Incorporated)OFC
Z-1915-2026Class IIPressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code...Arrow International LLC (subsidiary of Teleflex Incorporated)LRS
Z-1914-2026Class IIARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1913-2026Class IIFLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER...Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1912-2026Class IIPERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code...Arrow International LLC (subsidiary of Teleflex Incorporated)OFL
Z-1911-2026Class IIARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code...Arrow International LLC (subsidiary of Teleflex Incorporated)OFB
Z-1910-2026Class IIArrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code...Arrow International LLC (subsidiary of Teleflex Incorporated)OWL
Z-1855-2026Class IIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Intuitive Surgical, Inc.NAY
Z-1653-2026Class IIARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600...Siemens Medical Solutions USA, Inc.OWB
Z-1811-2026Class IIArjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USArjoHuntleigh Polska Sp. zo.o.FSA
Z-2206-2026Class IIARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono...Siemens Medical Solutions USA, Inc.OWB
Z-2205-2026Class IIARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB
Z-1897-2026Class IInanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft...Xtant Medical Holdings, Inc.MQV
Z-1944-2026Class IIVACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SSMilestone S.p.A.NNI
Z-1933-2026Class IILSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554LSL HealthcareOVN
Z-1932-2026Class IILSL Healthcare, IV Start Kit, Model/Catalog Number: 3131LSL HealthcareLRS
Z-1931-2026Class IILSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925HLSL HealthcareOXQ
Z-1930-2026Class IILSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555LSL HealthcareOIB
Z-1929-2026Class IILSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717JLSL HealthcareOXQ