LAPAROSCOPY PACK — Class I medical device recall Z-2418-2014
Terminated recall by Customed, Inc, reported 2014-09-10, distributed nationwide. Customed has determined that there is the possibility that packaging integrity may be compromised on different
| Recall number | Z-2418-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2014-08-29 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, DO, MX, TT |
| Reason classes | sterility, packaging |
| Lot numbers | 112030657, 112041913, 112051896, 112062467, 112114653, 112125043, 113026231, 113036784, 113057438, 113078284, 113088771, 113099399, 113109766, 131110211, 131210772, 140311185, 140412620, 140412878 |
Product
LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42" X 57" SMS (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18" X 18" XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2418-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.