{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "8 lots/123 units (multiple units per lot)",
      "code_info": "Product code 900-2234, 8 lots  112030726  113088792  113109792  131110112  131110338  140211660  140412835  140512993",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "EAR PACK  CONTENTS:  ( I )   B LADE SU RG ICA L # 15 CARBON STEEL   ( I  )   EMESI S BASIN  lO in 700cc  ( I )   GOWN XL SMS IM P. REINFORCED   ( I )  NEEDLE  HYPODERM IC 1 8G X I 'h  ( I )   WASH BASIN ROUND 6QT  ( I )  INSTRUMENT POUCH 7 X II  2COMPARTMENT   (I)  STERI STR I P CLOSURE 'h\" X 4\"  ( I)   SYRINGE 3cc WITHOUT NEEDLE    LILOCK   (2)   SYRINGE   I ML WITHOUT NEEDLE LILOCK   (I)  CAUTERY TIP POLISHER  (I)  SHEET ENT SPLIT  110\" X 77\" SMS  ( I )  GOWN I MP  XTRA REINF. SMS XLT/ W LEVEL I V   (2)   LITE GLOVE  (1 2) TOWELS CLOTH  HUCK (BLUE)  ( I )  TUBE SUCTION CONNECT  W' X 1 2'   (I)  EAR ULCER SYRINGE  2oz  (I)  TABLE COYER REINFORCED 50\" X 90\"  ( I)   UTILITY  BOWL 16oz  (4)   APPLICATOR  COTTON 6\" WOOD   (2)   STRJPS TAPE 24\" X 4\"  ( I )  GOWN LGE SMS I MPERVIOUS  REINFORCED ( I )  WIPE INSTRUMENT LMM 8.25 X 8.25\t  ( I )   MAYO STAND COYER REINFORCED  ( I )   NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I )   SYRINGE  I Occ WITHOUT  NEEDLE  LILOCK  ( I )   MAYOTRAY  SMALL  ( I )   SYRINGE  I Occ TI P CONTROL   LUER LOCK ( I )   DRAPE M ICROCOSPE  LE I CA 42 X 105  ( I )   TI ME OUT BEACON  NON WOVEN  (I)  BLADE M IN IATURE  CARBON STEEL   (10) GAUZE SPONGE  4\" X 4\" 1 6PLY XRD   (I)  SK I N MARKER INK W/8 LABEL  (2)   NEEDLE HYPODERM I C 27G X I W'    ONE PACK WET SK IN  W ITH CONTENTS:   ( I )    WRAPPER SMS 30\" X 30\"  (2)    COTTON TIP APPLICATOR 6\" WOOD   (2)    GLOVE MED FREETOUCH VYNIL P/F   (6)    SPONGE  W ING SMALL  (4)    TOWELS ABSORBENT  1 5\" X 20\"  (3)    TIP ABSORB.  APPLICATOR STI CK SPONGE   ( I )   PVP IODOPHOR  PAINT  4oz. BOTTLE  (I)\tPVP SCRUB SOLUTION 4oz. BOTTLE   (I)  TRAY 3/COMPARTMENT    Product  Usage:  EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2442-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}