Shoulder Arthroscopy Pack — Class I medical device recall Z-2500-2014
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-2500-2014 |
|---|---|
| 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 | 113047020, 113068032, 113078729 |
Product
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: 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-2500-2014. 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.