Data Foundry

Medical device recalls 2015

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133… — Class II medical device recall Z-2103-2015

Terminated recall by Allergan Inc, reported 2015-07-29. Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond

Recall numberZ-2103-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAllergan Inc, Irvine, CA, United States
Recall initiated2015-06-18
Classified2015-07-17
Reported by FDA2015-07-29
Terminated2015-12-16
Countries outside the USCA
Lot numbers11200803, 11201052, 11206048, 11206049, 11206681, 11237155, 11247636, 11250680, 11250691, 11250702, 11250734, 11254038, 11263982, 11267520, 11269154, 11269159, 11284363, 11307159, 11346491, 11347486, 11348914, 11367799, 11368096, 11372224, 11397846, 11406083, 11406084, 11406085, 11424452, 11458035, 11458039, 11458341, 11478944, 11514564, 11514565, 11560447, 11637421, 11650852, 11718948, 11729830 and 74 more
Serial numbers11200803, 11201052, 11206048, 11206049, 11206681, 11237155, 11247636, 11250680, 11250691, 11250702, 11250734, 11254038, 11263982, 11267520, 11269154, 11269159, 11284363, 11307159, 11346491, 11347486, 11348914, 11367799, 11368096, 11372224, 11397846 and 89 more

Product

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

Reason for recall

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

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-2103-2015. 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.