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 95 of 1190
FDA device recalls, page 95 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1309-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps...Aesculap IncHRQ
Z-1308-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy...Aesculap IncHGC
Z-1266-2025Class IIMiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895...Medtronic, Inc.OZP
Z-1265-2025Class IIMiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891...Medtronic, Inc.OZP
Z-1264-2025Class IIMiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)Medtronic, Inc.OYC
Z-1263-2025Class IIMiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)Medtronic, Inc.OYC
Z-1262-2025Class IIMiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)Medtronic, Inc.OZP
Z-1261-2025Class IIMiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781...Medtronic, Inc.OZP
Z-1260-2025Class IIMiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)Medtronic, Inc.OYC
Z-1259-2025Class IIMiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)Medtronic, Inc.OZO
Z-1258-2025Class IIMiniMed insulin pump, REF: 620G (MMT-1750)Medtronic, Inc.OYC
Z-1257-2025Class IIParadigm insulin pump, REF: MMT-754Medtronic, Inc.OYC
Z-1256-2025Class IIParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751Medtronic, Inc.OYC
Z-1255-2025Class IIParadigm REF: MMT-712 and MMT-715Medtronic, Inc.LZG
Z-1246-2025Class IMedtronic Pipeline Vantage Embolization Device with Shield Technology, REF...Medtronic, Inc.OUT
Z-1270-2025Class IIPhilips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;Telcare, LLCNBW
Z-1247-2025Class IIBrand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number...Leica Biosystems Nussloch GmbHIDP
Z-1245-2025Class IMedtronic Pipeline Vantage Embolization Device with Shield Technology, REF...Medtronic, Inc.OUT
Z-1328-2025Class IIStryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile...Stryker Corp.MBI
Z-1238-2025Class IIPentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes...PENTAX of America, Inc.PEA
Z-1237-2025Class IIPENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a...PENTAX of America, Inc.PEA
Z-1236-2025Class IIPENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a...PENTAX of America, Inc.PEA
Z-1046-2025Class IIOptima XR646 HD. X-Ray imaging system.GE HealthcareKPR
Z-1045-2025Class IIDiscovery XR656 HD. X-Ray imaging system.GE HealthcareKPR
Z-1044-2025Class IIDiscovery XR656HD. X-Ray imaging system.GE HealthcareKPR
Z-1043-2025Class IIDefinium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226...GE HealthcareKPR
Z-1434-2025Class IIPrelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/DMerit Medical Systems, Inc.DYB
Z-1294-2025Class IITISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAPTAS Medical IncGAR
Z-1276-2025Class IIOsstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is...Hiossen, Inc.NHA
Z-1275-2025Class IIET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant...Hiossen, Inc.NHA
Z-1274-2025Class IIOsstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is...Hiossen, Inc.NHA
Z-1273-2025Class IIET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant...Hiossen, Inc.NHA
Z-1272-2025Class IIET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant...Hiossen, Inc.NHA
Z-1271-2025Class IIET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant...Hiossen, Inc.NHA
Z-1204-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001Dexcom, Inc.QBJ
Z-1203-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001Dexcom, Inc.QBJ
Z-1202-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001Dexcom, Inc.QBJ
Z-1979-2025Class IIBrand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing...Guangzhou Pluslife Biotech Co., Ltd.QKP
Z-1978-2025Class IIBrand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog...Guangzhou Pluslife Biotech Co., Ltd.QKP
Z-1290-2025Class II(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H...Lumenis LtdGEX
Z-1231-2025Class IIBD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a...CareFusion 303, IncFRN
Z-1207-2025Class IIBD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex...CareFusion 303, IncBRY
Z-1226-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended...Tyber MedicalHRS
Z-1225-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for...Tyber MedicalHRS
Z-1224-2025Class IIA.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for...Tyber MedicalHRS
Z-1223-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended...Tyber MedicalHRS
Z-1222-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended...Tyber MedicalHRS
Z-1221-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended...Tyber MedicalHRS
Z-1220-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog...Tyber MedicalHRS
Z-1219-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for...Tyber MedicalHRS