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 113 of 1190
FDA device recalls, page 113 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0453-2025Class IIHalyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0452-2025Class IIHalyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0451-2025Class IIHalyard ENT - Medical convenience kits Model Number: VMED011-01Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0450-2025Class IIHalyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0449-2025Class IIHalyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0448-2025Class IIHalyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0447-2025Class IIHalyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0446-2025Class IIHalyard EP TRAY - Medical convenience kits Model Number: VAST038-04Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0445-2025Class IIHalyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0444-2025Class IIHalyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0443-2025Class IIHalyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0442-2025Class IIHalyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0441-2025Class IIHalyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0440-2025Class IIHalyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0439-2025Class IIHalyard EP PACK - Medical convenience kits Model Number: VANW018-06Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0438-2025Class IIHalyard RAD PACK - Medical convenience kits Model Number: VANW017-04Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0437-2025Class IIHalyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0436-2025Class IIHalyard GYN PAC - Medical convenience kits Model Number: SJGY20-02Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0435-2025Class IIHalyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0434-2025Class IIHalyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0433-2025Class IIHalyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0432-2025Class IIHalyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0431-2025Class IIHalyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0430-2025Class IIHalyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0429-2025Class IIHalyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0428-2025Class IIHalyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0427-2025Class IIHalyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0426-2025Class IIHalyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0425-2025Class IIHalyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0424-2025Class IIHalyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0423-2025Class IIHalyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0422-2025Class IIHalyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0421-2025Class IIHalyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0420-2025Class IIHalyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0419-2025Class IIHalyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0418-2025Class IIHalyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0417-2025Class IIHalyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0416-2025Class IIHalyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0415-2025Class IIHalyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0414-2025Class IIHalyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0413-2025Class IIHalyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0412-2025Class IIHalyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0411-2025Class IIHalyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0410-2025Class IIHalyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0409-2025Class IIHalyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0408-2025Class IIHalyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0407-2025Class IIHalyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0406-2025Class IIHalyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0405-2025Class IIHalyard GYN TRAY - Medical convenience kits Model Number: LANC014-19Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0404-2025Class IIHalyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25Avid Medical, Inc. a Medical Action Ind. Company 305LRO