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 148 of 1190
FDA device recalls, page 148 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2050-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2049-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2048-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2047-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2046-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2045-2024Class IIBrand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2044-2024Class IIBrand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2043-2024Class IIBrand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2042-2024Class IIBrand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2171-2024Class IICARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001...GE Healthcare Finland OyMHX
Z-2170-2024Class IICARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2...GE Healthcare Finland OyMHX
Z-2169-2024Class IICARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c)...GE Healthcare Finland OyMHX
Z-2168-2024Class IICARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169...GE Healthcare Finland OyMHX
Z-1808-2024Class IIWishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.Wishbone Medical, Inc.OBT
Z-1708-2024Class IIIPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1707-2024Class IIIPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1706-2024Class IIIPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1705-2024Class IIIPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1704-2024Class IIIPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1703-2024Class IIIPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication...Ivoclar Vivadent, Inc.EIH
Z-1786-2024Class IIIEvidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative...Randox Laboratories, LimitedJJE
Z-1252-2025Class IIPhilips IntelliSpace Cardiovascular software, Model 830089.Philips Medical Systems Nederland B.V.LLZ
Z-1885-2024Class II8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis...Stryker Leibinger GmbH & Co. KGPGW
Z-1834-2024Class IIReagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones...Macherey Nagel GmbH & Co. KGJIL
Z-1888-2024Class IIInstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans...OLYMPUS Corporation of the AmericasEOB
Z-1740-2024Class IIThe Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter...Stryker Corp.DQY
Z-1919-2024Class IIBrand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer...Agilent Technologies, Inc.KPA
Z-1823-2024Class IIAirvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100USFisher & Paykel Healthcare, Inc.BTT
Z-1828-2024Class IISterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)Andover Healthcare Inc.FQM
Z-1817-2024Class IOmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 11...Respironics, Inc.MNS
Z-1833-2024Class IIEchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520Cook Medical LLCFCG
Z-1832-2024Class IIEchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012Cook Medical LLCFCG
Z-1809-2024Class IILASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF...Karl Storz Endoscopy-America, Inc.GEX
Z-1935-2024Class IILOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product...Corentec Co., Ltd.JWH
Z-1934-2024Class IILOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product...Corentec Co., Ltd.JWH
Z-1785-2024Class IIStryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization...Stryker Leibinger GmbH & Co. KGGWO
Z-1756-2024Class IIThe Oncology Essentials Package of the Spectral CT imaging system.Philips North America LLCJAK
Z-2166-2024Class IIHORIBA custom configured fluorescence instrument, modular Fluorolog-QMHoriba Instruments IncorporatedREM
Z-1752-2024Class IIRayStation 15.0.0.430. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1751-2024Class IIRayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1750-2024Class IIRayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1749-2024Class IIRayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy...RaySearch Laboratories AB (publ)MUJ
Z-1748-2024Class IIRayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment...RaySearch Laboratories AB (publ)MUJ
Z-1747-2024Class IIRayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1746-2024Class IIRayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1745-2024Class IIRayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1744-2024Class IIRayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1743-2024Class IIRayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1742-2024Class IIRayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ
Z-1741-2024Class IIRayStation 7.0.0.19. Radiation Therapy Treatment Planning System.RaySearch Laboratories AB (publ)MUJ