E — Class I medical device recall Z-2395-2014
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-2395-2014 |
|---|---|
| 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 | 110102428, 110112608, 110123088, 111010049, 111020265, 111030581, 111040888, 111051317, 111061497, 111071865, 111082190, 111092354, 111102683, 111113009, 111123347, 112010050, 112020371, 112030620, 112041188, 112051766, 112062419, 112083396, 112093898, 112124950, 112125282, 113025940, 113036669, 113047197, 113067888, 113068256, 113078256, 113109732, 131210747, 140111083, 140211641, 140312070, 140312453, 140513090, 140613609 |
Product
E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15" X 20" L/F (1) DRAPE SHEET 41 " X 58" SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER 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-2395-2014. 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.