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 160 of 1190
FDA device recalls, page 160 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1230-2024Class IIVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Ortho-Clinical Diagnostics, Inc.JJE
Z-1229-2024Class IIVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914...Ortho-Clinical Diagnostics, Inc.JJE
Z-1228-2024Class IIVITROS XT 7600 Integrated System, Catalog No. 6844461Ortho-Clinical Diagnostics, Inc.JJE
Z-1227-2024Class IIVITROS XT 3400 Chemistry System, Catalog No. 6844458Ortho-Clinical Diagnostics, Inc.JJE
Z-1226-2024Class IIVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Ortho-Clinical Diagnostics, Inc.JJE
Z-1225-2024Class IIVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Ortho-Clinical Diagnostics, Inc.JJE
Z-1224-2024Class IIVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914...Ortho-Clinical Diagnostics, Inc.JJE
Z-1182-2024Class IIIdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 /...Alphatec Spine, Inc.OVD
Z-1185-2024Class IISchiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black...EMD Millipore CorporationHZT
Z-1140-2024Class IIFilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test...BioFire Diagnostics, LLCPCH
Z-1139-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic...BioFire Diagnostics, LLCPEN
Z-1697-2024Class IISofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile...Medtronic, Inc.GAP
Z-1143-2024Class IIIonolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122...Voco GmbHEMA
Z-1595-2024Class IISW Bari Lift & Transfer, Model Number 38060000Agiliti Health - HaysFNG
Z-1142-2024Class IIIonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f)...Voco GmbHEMA
Z-1322-2024Class IIimpression coping, repositionable, short, screw-retained, PF 4.0Thommen Medical AGNDP
Z-1281-2024Class IIADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics Inc.GGT
Z-1280-2024Class IIAtellica IM Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics Inc.GGT
Z-1242-2024Class IIOpal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine...Synthes (USA) Products LLCN/A
Z-1241-2024Class IIVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone...Synthes (USA) Products LLCHRS
Z-1240-2024Class IITFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and...Synthes (USA) Products LLCHSB
Z-1239-2024Class IITFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and...Synthes (USA) Products LLCHSB
Z-1238-2024Class IIRAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair...Synthes (USA) Products LLCHBW
Z-1237-2024Class IIRIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and...Synthes (USA) Products LLCHTO
Z-1236-2024Class II2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered &...Synthes (USA) Products LLCHSZ
Z-1235-2024Class II1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered &...Synthes (USA) Products LLCHSZ
Z-1234-2024Class II13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate...Synthes (USA) Products LLCHSB
Z-1327-2024Class Istay-safe /Luer Catheter Ext. 6 inFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-1326-2024Class Istay-safe /Luer Lock Catheter Ext. 18 inFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-1325-2024Class Istay-safe /Luer Lock Catheter Ext. 12 inFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-1324-2024Class Istay-safe /Luer Lock Adapter 4 inFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-1323-2024Class Istay-safe /Safe Lock Catheter Ext. 12 inFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-1295-2024Class IICVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains...MEDLINE INDUSTRIES, LP - NorthfieldNAC
Z-1754-2024Class IIBattery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model...Sedecal S.A.IZL
Z-1219-2024Class IILINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for...Waldemar Link GmbH & Co. KGLZO
Z-1166-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar...Medtronic NeurosurgeryPCB
Z-1165-2024Class IMedtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites...Medtronic NeurosurgeryPCB
Z-1164-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites...Medtronic NeurosurgeryPCB
Z-1163-2024Class IMedtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF...Medtronic NeurosurgeryPCB
Z-1162-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF...Medtronic NeurosurgeryPCB
Z-1222-2024Class IIVITROS XT7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.JJE
Z-1221-2024Class IIVITROS 5600 Integrated System (New and Refurbished)Ortho-Clinical Diagnostics, Inc.JJE
Z-1220-2024Class IIVITROS 3600 Immunodiagnostic System (New and Refurbished)Ortho-Clinical Diagnostics, Inc.JJE
Z-1204-2024Class IITensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes...Parker Laboratories, Inc.GYB
Z-1150-2024Class IIEpidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray...B Braun Medical IncOGE
Z-1149-2024Class IIEpidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound...B Braun Medical IncOGE
Z-1251-2024Class IIInvacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model...Invacare GmbHLLI
Z-2094-2025Class IIITrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that...Stratasys Inc.EBI
Z-2093-2025Class IIITrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that...Stratasys Inc.EBI
Z-2092-2025Class IIITrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that...Stratasys Inc.EBI