3M Healthcare Business: Medical Device Recall in 2022 - (Recall #: Z-0263-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape

Product Classification:

Class II

Date Initiated: October 6, 2022

Date Posted: November 30, 2022

Recall Number: Z-0263-2023

Event ID: 90989

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.

Status: Ongoing

Product Quantity: 554,200 units

Code Information:

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

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated