Recall archive / FDA device enforcement
3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape — FDA record Z-0263-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 6, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- 3M Healthcare Business
- Quantity
- 554,200 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0263-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI (01)50707387074079, Lot numbers: 33HCPF, 33HD5K, 33HDAN, 33HDXM, 33HEDT, 33HELW, 33HEXM, 33HJRY, 33HJXT, 33HK99, 33HKJJ, 33HLFP, 33HLXW, 33HM9X, 33HMHE, 33HMWN, 33HNLK, 33HNW9, 33HP9A, 33HPJF, 33HPWN, 33HR5W, 33HRF9, 33HRRM, 33HX8N, 33J3LR, 33J438, 33J4CX, 33J4LN, 33J4WC, 33J5ER, 33J5PJ, 33J643, 33J6DF, 33J6KR, 33J9AK, 33J9HM, 33J9R6, 33JA7J, 33JAE8, 33JC6Y, 33JCHF, 33JCR8, 33JD59, 33JDFC, 33JE48, 33JEET, 33JEMN, 33JEYL, 33JFK6, 33JHA7, 33JKDR, 33JKMK, 33JKYM, 33JLD4, 33JLKN, 33JXF6, 33JXMY, 33JY79, 33JYDR, 33JYNF, 33K3A3, 33K3N3, 33K43M, 33K4AT, 33K5FA, 33K5NL, 33K64F, 33K6AE, 33K79D, 33K7JL, 33K7X9, 33K89R, 33KATM, 33KCAF, 33KCJ3, 33KCY5, 33KD7E, 33KE33, 33KE9D, 33KEKL, 33KF3M, 33KFAH, 33KN4W, 33KNCR, 33KNLE, 33KNYE, 33KPHW, 33KR3A, 33KRAF, 33KRNF, 33KTNL, 33KW4L, 33KWEW, 33KWR5, 33KXX6, 33KY84, 33KYHP, 33L8HN, 33L8TL, 33L97A, 33L9WX, 33LA8J, 33LAJY, 33LAY6, 33LCYM, 33LDDF, 33LDN3, 33LDYL, 33LEDD, 33LF6E, 33LFEA, 33LFNT, 33LH67, 33LHCW, 33LJ9Y, 33LJJ6 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 30, 2022
- Recall initiation date
- Oct 6, 2022
- Center classification date
- Nov 18, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.