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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

59,486 records, page 350 of 1190
FDA device recalls, page 350 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1622-2020Class IIPhilips V60 Ventilators with Power Management PCBA part number 1055906Respironics, Inc.MNT
Z-1687-2020Class IIGEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of...Baxter Healthcare CorporationMVR
Z-1686-2020Class IIGEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in...Baxter Healthcare CorporationMVR
Z-1685-2020Class IIGEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in...Baxter Healthcare CorporationMVR
Z-1598-2020Class IIRayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7...RaySearch Laboratories AB (publ)MUJ
Z-1699-2020Class IISTA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted...Diagnostica Stago, Inc.GGP
Z-2327-2020Class IIInfinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This...Canon Medical Systems USA, Inc.MQB
Z-2326-2020Class IIInfinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This...Canon Medical Systems USA, Inc.OWB
Z-2325-2020Class IIInfinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This...Canon Medical Systems USA, Inc.OWB
Z-1564-2020Class IICaptus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product...Mirion Technologies (Capintec), Inc.IZD
Z-1790-2020Class IISiemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient...CSL Behring LLCNAO
Z-1632-2020Class IIMerits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.Merits Health Products, Inc.KNO
Z-1553-2021Class IIReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the...Lifeward, Inc.PHL
Z-1820-2020Class IIPortex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex...Abbott MedicalCAZ
Z-1700-2020Class IIMerlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient...Abbott MedicalNIK
Z-1713-2020Class IIIWallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units)...CooperSurgical, Inc.MFD
Z-0305-2021Class IICMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL...CME America, LLCFRN
Z-1797-2020Class IIAtellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0...Siemens Healthcare Diagnostics Inc.JGS
Z-2521-2020Class IIuDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a...Shanghai United Imaging Healthcare Co., Ltd.KPR
Z-1634-2020Class IINAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is...Smith & Nephew, Inc.OLO
Z-1604-2020Class IIDeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138...DeRoyal Industries, Inc.FMQ
Z-1626-2020Class IIGentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare...GentellFRO
Z-1625-2020Class IIGentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a...GentellFRO
Z-1624-2020Class IIGentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a...GentellFRO
Z-1623-2020Class IIGentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a...GentellFRO
Z-2536-2020Class IIThe CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal...CapsoVision, Inc.NEZ
Z-1759-2020Class IISynaptive ImageDrive ClinicalSynaptive Medical IncLLZ
Z-2082-2020Class IIBARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435Becton Dickinson & CoLJS
Z-2081-2020Class IIBARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418BBecton Dickinson & CoLJS
Z-2080-2020Class IIBARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417BBecton Dickinson & CoLJS
Z-2079-2020Class IIBARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278Becton Dickinson & CoLJS
Z-2078-2020Class IIBARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277Becton Dickinson & CoLJS
Z-2077-2020Class IIBARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276Becton Dickinson & CoLJS
Z-2076-2020Class IIBARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026ABecton Dickinson & CoLJS
Z-2075-2020Class IIBARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025Becton Dickinson & CoLJS
Z-1670-2020Class IIBIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI...Zimmer GmbHKWY
Z-1669-2020Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.Zimmer GmbHJWH
Z-1668-2020Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.Zimmer GmbHJWH
Z-1667-2020Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.Zimmer GmbHJWH
Z-1666-2020Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.Zimmer GmbHJWH
Z-1665-2020Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.Zimmer GmbHJWH
Z-1664-2020Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.Zimmer GmbHJWH
Z-1663-2020Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.Zimmer GmbHJWH
Z-1662-2020Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.Zimmer GmbHJWH
Z-1661-2020Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile...Zimmer GmbHKWS
Z-1660-2020Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile...Zimmer GmbHKWS
Z-1659-2020Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile...Zimmer GmbHKWS
Z-1658-2020Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile...Zimmer GmbHKWS
Z-1657-2020Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile...Zimmer GmbHKWS
Z-1656-2020Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone...Zimmer GmbHKWY