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 32 of 1187
FDA device recalls, page 32 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1774-2026Class IISee Luer Cap Set, MPC-130, set, administration, intravascularMolded Products IncFPA
Z-2701-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog...Encore Medical, LPJWH
Z-2700-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog...Encore Medical, LPJWH
Z-1711-2026Class IIMedline Anterior Hip Pack Dynj64672bMEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1710-2026Class IIMedline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1709-2026Class IIMedline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1708-2026Class IIMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1707-2026Class IIThoracic Robots, Dynj908777bMEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1706-2026Class IIMedline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2...MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-1705-2026Class IIAirway Exam Kit, DYKE1796MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1584-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423657 10-35mmConvaTec LimitedFON
Z-1583-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423653 10-35mmConvaTec LimitedFON
Z-1582-2026Class IIConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mmConvaTec LimitedFON
Z-1591-2026Class IAutomated Impella Controller (AIC), labeled as the following with corresponding Product...Abiomed, Inc.OZD
Z-1752-2026Class IIParadigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)Medtronic, Inc.N/A
Z-1751-2026Class IIMiniMed 530G Insulin Pump (MMT-551, MMT-751)Medtronic, Inc.OZO
Z-1750-2026Class IIParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)Medtronic, Inc.OYC
Z-1749-2026Class IIParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)Medtronic, Inc.OYC
Z-1748-2026Class IIParadigm Insulin Pump (MMT-712, MMT-715)Medtronic, Inc.LZG
Z-1747-2026Class IIMiniMed 620G Insulin Pump (MMT-1750)Medtronic, Inc.OYC
Z-1746-2026Class IIMiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)Medtronic, Inc.OYC
Z-1745-2026Class IIMiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)Medtronic, Inc.OYC
Z-1744-2026Class IIMiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)Medtronic, Inc.N/A
Z-1743-2026Class IIMiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)Medtronic, Inc.OYC
Z-1742-2026Class IIMiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)Medtronic, Inc.OZP
Z-1691-2026Class IIMedline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU...MEDLINE INDUSTRIES, LP - NorthfieldPIO
Z-1690-2026Class IIENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GCMEDLINE INDUSTRIES, LP - NorthfieldPIO
Z-1741-2026Class IIMiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)Medtronic, Inc.QFG
Z-1740-2026Class IIMiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)Medtronic, Inc.OZO
Z-1579-2026Class IBioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU...Merit Medical Systems, Inc.MSD
Z-1578-2026Class IDuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A...Merit Medical Systems, Inc.MSD
Z-1577-2026Class I16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/BMerit Medical Systems, Inc.DYB
Z-1576-2026Class IProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C...Merit Medical Systems, Inc.MSD
Z-1575-2026Class ICentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A...Merit Medical Systems, Inc.MSD
Z-1739-2026Class IIMiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)Medtronic, Inc.OZP
Z-1568-2026Class IFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useErbe USA IncGEH
Z-1567-2026Class IFlexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useErbe USA IncGEH
Z-1566-2026Class IFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF...Erbe USA IncGEH
Z-1613-2026Class IIOlympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.OLYMPUS Corporation of the AmericasFEB
Z-1612-2026Class IIOlympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.OLYMPUS Corporation of the AmericasFEB
Z-1611-2026Class IIOlympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.OLYMPUS Corporation of the AmericasODC
Z-1610-2026Class IIOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.OLYMPUS Corporation of the AmericasODC
Z-2524-2026Class IITMJ Bilateral Implants, REF: CHG020TMJ Solutions, LLCLZD
Z-1765-2026Class IIBurlington Medical, Kilt Blockers.Burlington Medical LLCIWO
Z-1764-2026Class IIBurlington Medical, Blockers.Burlington Medical LLCIWO
Z-1763-2026Class IIBurlington Medical, Demi Half Aprons.Burlington Medical LLCIWO
Z-1762-2026Class IIBurlington Medical, Half Aprons.Burlington Medical LLCIWO
Z-1761-2026Class IIBurlington Medical, Leg Wraps.Burlington Medical LLCIWO
Z-1760-2026Class IIBurlington Medical, Caps.Burlington Medical LLCIWO
Z-1759-2026Class IIBurlington Medical, Protective Sleeves.Burlington Medical LLCIWO