3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
FDA Device Recall #Z-0247-2023 — Class II — October 6, 2022
Recall Summary
| Recall Number | Z-0247-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 6, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | 3M Healthcare Business |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 503,600 units |
Product Description
3M Steri-Drape, Small Towel Drape, REF 1000, 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.
Distribution Pattern
Worldwide distribution.
Lot / 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
Other Recalls from 3M Healthcare Business
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0253-2023 | Class II | 3M Steri-Drape, Small Drape with Adhesive Apert... | Oct 6, 2022 |
| Z-0250-2023 | Class II | 3M Steri-Drape, Large Towel Drape, REF 1010, ge... | Oct 6, 2022 |
| Z-0260-2023 | Class II | 3M Steri-Drape, Medium Drape with Incise Film, ... | Oct 6, 2022 |
| Z-0249-2023 | Class II | 3M Steri-Drape, Small Towel Drape, REF 1000NSD,... | Oct 6, 2022 |
| Z-0264-2023 | Class II | 3M Steri-Drape, Urological Drape, REF 1071, gen... | Oct 6, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.