Data Foundry

Medical device recalls 2016

American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product… — Class II medical device recall Z-1752-2016

Terminated recall by American Surgical Company, reported 2016-06-01, distributed nationwide. Product packaging defective compromising sterility

Recall numberZ-1752-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAmerican Surgical Company, Salem, MA, United States
Recall initiated2016-03-31
Classified2016-05-26
Reported by FDA2016-06-01
Terminated2016-10-21
DistributedNationwide (US)
Countries outside the USAU, BE, CA, CH, DE, ES, FR, GB, GR, HK, IL, IT, JP, NL, NZ, PT, SA, SE, ZA
Quantity27 boxes
Reason classessterility, packaging
Lot numbers2015/09BZ, 2015/11BA
Model numbers23-24

Product

American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Reason for recall

Product packaging defective compromising sterility

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-1752-2016. 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.