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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90989

18 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 06, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
3M Healthcare Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

18 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 18

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

Z-0247-2023
Recall number
Z-0247-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
503,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387057245, Lot Numbers: 33HD8F, 33HDDH, 33HDK3, 33HDR6, 33HDXN, 33HECP, 33HEM4, 33HF3E, 33HFAM, 33HFFJ, 33HFNY, 33HFTH, 33HTJR, 33HTNP, 33HTYL, 33HW9C, 33HWMN, 33HX4N, 33HXRF, 33HY4P, 33HYA7, 33HYLK, 33J5L5, 33J5T7, 33J639, 33J6EN, 33J6KE, 33J6R5, 33J763, 33J7ED, 33J7ML, 33J7X8, 33J89T, 33J8LE, 33JK67, 33JKCL, 33JKLR, 33JL35, 33JLDA, 33JLJ4, 33JTE3, 33JTPP, 33JW5A, 33JWAR, 33K35Y, 33K3DP, 33K3L9, 33K444, 33K4D4, 33K4JP, 33K4YY, 33K54E, 33K5CH, 33K5N9, 33K63K, 33K7CM, 33K7J8, 33K7WC, 33K88L, 33K8H6, 33K8KM, 33K8Y7, 33K95A, 33K9J6, 33K9NX, 33KA3R, 33KA7X, 33KADW, 33KX6W, 33KXDH, 33KXKH, 33L8CR, 33L8WC, 33L97L, 33L9CD, 33L9LD, 33L9XD, 33LACE, 33LAKN, 33LATP, 33LC4T, 33LCHH, 33LCNA, 33LD68, 33LJD4, 33LJJY

Distribution pattern

Worldwide distribution.

device · product 2 of 18

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

Z-0248-2023
Recall number
Z-0248-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
504,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387023381, Lot Numbers: 33HP4H, 33HPDN, 33HPLM, 33HPWP, 33J478, 33J8MT, 33J948, 33JLMY, 33JLWL, 33K6FN, 33KCDK, 33KCP4, 33KY37, 33KYDK, 33KYNY

Distribution pattern

Worldwide distribution.

device · product 3 of 18

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

Z-0249-2023
Recall number
Z-0249-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
248,750 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387445701, Lot Numbers: 33HCR7, 33HD4C, 33J4J6, 33J4NF, 33JRKR, 33JRYN, 33JT7E, 33K6D6, 33KAH8, 33KAMP, 33KAY7, 33KC8K

Distribution pattern

Worldwide distribution.

device · product 4 of 18

3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape

Z-0250-2023
Recall number
Z-0250-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
2,779,810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387057252, Lot numbers: 33HAET, 33HAPR, 33HAYX, 33HC8R, 33HCEX, 33HH47, 33HHC9, 33HHKA, 33HHTA, 33HJA9, 33HJH7, 33HJNT, 33HK4K, 33HKD8, 33HKHT, 33HKPP, 33HKRT, 33HL59, 33HL9X, 33HLLW, 33HLXD, 33HMAD, 33HMJH, 33HMWA, 33HN5C, 33HND4, 33HNWM, 33HYNH, 33HYTN, 33J33L, 33J37F, 33J3EL, 33J3NC, 33J44N, 33J9CP, 33J9FN, 33J9TH, 33JA7C, 33JADN, 33JAMH, 33JATF, 33JC94, 33JCK8, 33JCMJ, 33JD45, 33JDF6, 33JDPK, 33JDT4, 33JFDY, 33JFHJ, 33JHAC, 33JHJ4, 33JJ4H, 33JJ9P, 33JJF7, 33JJT9, 33JM5W, 33JMDH, 33JMKP, 33JMTJ, 33JN8N, 33JNNF, 33JPHR, 33JPKT, 33JPWT, 33KDER, 33KDMN, 33KDY5, 33KE9E, 33KEL3, 33KF3N, 33KF83, 33KFRC, 33KFY9, 33KH7R, 33KHCM, 33KHLJ, 33KHX3, 33KJ63, 33KJEX, 33KJNK, 33KK5D, 33KKC4, 33KLHM, 33KLNH, 33KLWJ, 33KM9K, 33KMJH, 33KMLN, 33KN3J, 33KNAJ, 33KNN4, 33KNXW, 33KP63, 33KPJY, 33KPYP, 33KRC5, 33KRPW, 33KT57, 33KT9N, 33KTEM, 33L4D6, 33L4K4, 33L4X5, 33L5C7, 33L5P5, 33L5X3, 33L64A, 33L6D7, 33L6N4, 33L6XH, 33L7AM, 33L7FX, 33L7XL, 33L878, 33LDF8, 33LDPJ, 33LED4, 33LETX, 33LF49, 33LFJ9, 33LFPM, 33LH6E

Distribution pattern

Worldwide distribution.

device · product 5 of 18

3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape

Z-0251-2023
Recall number
Z-0251-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
807,720 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387023756, Lot numbers: 33HR7D, 33HR94, 33HRET, 33HRWK, 33HT5X, 33HTDY, 33J4XP, 33J583, 33J5FA, 33JEF8, 33JEM5, 33JEYA, 33JWHK, 33JWLX, 33JWRH, 33JX5M, 33JXFA, 33JXPK, 33JY6E, 33JYEM, 33JYM4, 33JYXH, 33KD6N, 33KKET, 33KKMT, 33KL65, 33KLAR, 33L34N, 33L3JN, 33L3LT, 33L44T, 33LLC5

Distribution pattern

Worldwide distribution.

device · product 6 of 18

3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape

Z-0252-2023
Recall number
Z-0252-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
84,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387445718, Lot numbers: 33JE6A, 33JR86, 33JRFK, 33KD3C

Distribution pattern

Worldwide distribution.

device · product 7 of 18

3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape

Z-0253-2023
Recall number
Z-0253-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
769,810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387018772, Lot numbers: 33H9T5, 33HA9D, 33HC7R, 33HCJN, 33HCPL, 33HD6C, 33HDYW, 33HEDM, 33HELH, 33HF3X, 33HFXP, 33HH8C, 33HHKC, 33HJ3K, 33HK5H, 33HKJH, 33HKPA, 33HLKE, 33HLWT, 33HNJ3, 33HNXX, 33HY4Y, 33HYCP, 33J3LW, 33J43T, 33J4E7, 33J4M7, 33J5CP, 33J798, 33J7KC, 33J7YJ, 33J8A7, 33J97T, 33J9JR, 33J9RC, 33JA5D, 33JAED, 33JC7L, 33JCHH, 33JCPY, 33JD5A, 33JE49, 33JEEM, 33JEP8, 33JFAJ, 33JFJX, 33JPDM, 33JPPC, 33JR3D, 33JRCR, 33JRNA, 33JTFX, 33JTNY, 33JW4L, 33JWD4, 33JWLR, 33JXEM, 33JXRJ, 33JY7J, 33JYFL, 33JYMH, 33K3AE, 33K3N7, 33K6CJ, 33K7CL, 33K7NF, 33K9A3, 33K9JW, 33K9R5, 33K9YW, 33KAXL, 33KC8P, 33KCJT, 33KCX3, 33KE37, 33KHXA, 33KJAA, 33KJL5, 33KJWK, 33KKMY, 33KL5W, 33KLMN, 33KM4C, 33KN54, 33KNAX, 33KR5C, 33KRDE, 33KRR5, 33KTNC, 33KW4K, 33KWEX, 33KWT5, 33KXRH, 33KYA3, 33KYKA, 33KYWT, 33L3YR, 33L6EW, 33L6M5, 33L7RH

Distribution pattern

Worldwide distribution.

device · product 8 of 18

3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape

Z-0254-2023
Recall number
Z-0254-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
220,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387226850, Lot numbers: 33HPA7, 33HPMC, 33HRTD, 33JHA8, 33JHNK, 33JJAJ, 33K44C, 33K4DT, 33K5J8, 33K5TD, 33KEAT, 33KFCA, 33KFMN, 33KH4C, 33L47C, 33L55C, 33LJL7

Distribution pattern

Worldwide distribution.

device · product 9 of 18

3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

Z-0255-2023
Recall number
Z-0255-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
36,020 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387058204, Lot numbers: 33H9HW, 33HXMD, 33JKD4, 33JKLL, 33KPXJ

Distribution pattern

Worldwide distribution.

device · product 10 of 18

3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

Z-0256-2023
Recall number
Z-0256-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
104,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387497410, Lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, 33K888

Distribution pattern

Worldwide distribution.

device · product 11 of 18

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape

Z-0257-2023
Recall number
Z-0257-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
41,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387018765, Lot numbers: 33HFW5, 33HH8Y, 33JRFA, 33JTD4, 33KKLW, 33KL53

Distribution pattern

Worldwide distribution.

device · product 12 of 18

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape

Z-0258-2023
Recall number
Z-0258-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
43,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)50707387029352, Lot numbers: 33JPRN, 33JPWY, 33JR98, 33KLEY, 33KLME

Distribution pattern

Worldwide distribution.

device · product 13 of 18

3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape

Z-0259-2023
Recall number
Z-0259-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
14,360 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)3070387454587, Lot numbers: 33H9JH, 33J6KY, 33JCP7, 33JRD4, 33JYJ5, 33K6E3, 33KFAC, 33KHKL, 33L6E6, 33LAXJ

Distribution pattern

Worldwide distribution.

device · product 14 of 18

3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape

Z-0260-2023
Recall number
Z-0260-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
26,160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387018758, Lot numbers: 33HT6E, 33HWFM, 33HWMF, 33HX3K, 33K9TF, 33KA3T, 33KA95

Distribution pattern

Worldwide distribution.

device · product 15 of 18

3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape

Z-0261-2023
Recall number
Z-0261-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
103,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01) 50707387029369, Lot numbers: 33J7AA, 33J7JY, 33J7W8, 33J8AX, 33J8JR, 33JM8K, 33JMKC, 33JMW3, 33JN9L, 33JNHN, 33JPE6, 33JPM8, 33K8HC, 33K966, 33K9FK

Distribution pattern

Worldwide distribution.

device · product 16 of 18

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

Z-0262-2023
Recall number
Z-0262-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
63,840 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI (01)30707387074068, Lot numbers: 33HAEY, 33HC74, 33HCHP, 33JHMA, 33JHYT, 33JJ8X, 33JJHM, 33JTNP, 33JW4J, 33JWDD, 33JWLT, 33KFNC, 33KFY5, 33KHK3, 33KHWN, 33KJ7L, 33KJJ7, 33KJTC, 33KYY7, 33L4L6

Distribution pattern

Worldwide distribution.

device · product 17 of 18

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

Z-0263-2023
Recall number
Z-0263-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
554,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 18 of 18

3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape

Z-0264-2023
Recall number
Z-0264-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Recalling firm
3M Healthcare Business
Quantity
17,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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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.

Code information

UDI/DI (01)30707387018741, Lot numbers: 33HJ3C, 33HTFH, 33J9CT, 33JED6, 33JJHN, 33K968, 33KTRH

Distribution pattern

Worldwide distribution.