Data Foundry

Medical device recalls 2022

3M Steri-Drape — Class II medical device recall Z-0248-2023

Ongoing recall by 3M Healthcare Business, reported 2022-11-30. During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is diff

Recall numberZ-0248-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firm3M Healthcare Business, Saint Paul, MN, United States
Recall initiated2022-10-06
Classified2022-11-18
Reported by FDA2022-11-30
Quantity504,000 units
UPC / GTIN / UDI-DI50707387023381
Lot numbers33HP4H, 33HPDN, 33HPLM, 33HPWP, 33J478, 33J8MT, 33J948, 33JLMY, 33JLWL, 33K6FN, 33KCDK, 33KCP4, 33KY37, 33KYDK, 33KYNY
Model numbers1000NS

Product

3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape

Reason for recall

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

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-0248-2023. 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.