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 18 of 1187
FDA device recalls, page 18 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2562-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs...Surgify Medical OyHBE
Z-2561-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs...Surgify Medical OyHBE
Z-2560-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs...Surgify Medical OyHBE
Z-2559-2026Class IISurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs...Surgify Medical OyHBE
Z-2558-2026Class IISurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs...Surgify Medical OyHBE
Z-2557-2026Class IISurgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines...Surgify Medical OyHBE
Z-2556-2026Class IISurgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs...Surgify Medical OyHBE
Z-2555-2026Class IISurgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs...Surgify Medical OyHBE
Z-2283-2026Class IIBrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid...Advanced Bionics LLCMCM
Z-2912-2026Class IIBOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BG...Terumo Cardiovascular Systems CorporationDQY
Z-2352-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2351-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2350-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2349-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2348-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2347-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit...Halyard HealthKNT
Z-2346-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr...Halyard HealthKNT
Z-2345-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr...Halyard HealthKNT
Z-2344-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr...Halyard HealthKNT
Z-2343-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH...Halyard HealthKNT
Z-2342-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH...Halyard HealthKNT
Z-2341-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH...Halyard HealthKNT
Z-2340-2026Class IIProduct Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number...Halyard HealthKNT
Z-2339-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6312Halyard HealthKNT
Z-2338-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320Halyard HealthKNT
Z-2337-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-4320Halyard HealthKNT
Z-2336-2026Class IIProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316Halyard HealthKNT
Z-2335-2026Class IIProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312Halyard HealthKNT
Z-2334-2026Class IIBrand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320Halyard HealthKNT
Z-2333-2026Class IIBrand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320Halyard HealthKNT
Z-2304-2026Class IIBD Pyxis MedBank Mini REF: 1147-00 Medication cabinetCareFusion 303, IncBRY
Z-2303-2026Class IIBD Pyxis MedBank Tower REF: 1145-00 Medication cabinetCareFusion 303, IncBRY
Z-2302-2026Class IIBD Pyxis MedStation ES Tower REF: 352 Medication cabinetCareFusion 303, IncBRY
Z-2301-2026Class IIBD Pyxis Mini Main REF: 349 Medication cabinetCareFusion 303, IncBRY
Z-2300-2026Class IIBD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinetCareFusion 303, IncBRY
Z-2299-2026Class IIBD Pyxis Anesthesia Station ES REF: 327 Medication cabinetCareFusion 303, IncBRY
Z-2298-2026Class IIBD Pyxis MedStation ES REF: 323 Medication cabinetCareFusion 303, IncBRY
Z-2297-2026Class IIBD Pyxis MedStation 4000 REF: 303 Medication cabinetCareFusion 303, IncBRY
Z-2259-2026Class IIAllura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010...Philips Medical Systems Nederland B.V.OWB
Z-2258-2026Class IIAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221)...Philips Medical Systems Nederland B.V.OWB
Z-2324-2026Class IITDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27...D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE
Z-2323-2026Class IITDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25...D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE
Z-2322-2026Class IITDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23...D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE
Z-2404-2026Class IIBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180Boston Scientific Neuromodulation CorporationLGW
Z-2403-2026Class IIBoston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm...Boston Scientific Neuromodulation CorporationGXI
Z-2402-2026Class IIBoston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x...Boston Scientific Neuromodulation CorporationGXI
Z-2834-2026Class IIREMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info...Beckman Coulter Biomedical GmbHJQP
Z-2319-2026Class IIMahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual...Mozarc Medical US LLCMPB
Z-2313-2026Class IIPlum Duo Precision IV Pump, 40002-0403Abbott MedicalFRN
Z-2312-2026Class IIPlum Duo Infusion Pump, 40002-0401Abbott MedicalFRN