WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), ...
FDA Device Recall #Z-1499-2023 — Class II — March 23, 2023
Recall Summary
| Recall Number | Z-1499-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 23, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ASO LLC |
| Location | Sarasota, FL |
| Product Type | Devices |
| Quantity | 919 cases of 24 units |
Product Description
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
Reason for Recall
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Distribution Pattern
US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI
Lot / Code Information
UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.
Other Recalls from ASO LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1517-2022 | Class II | (1) CVS Health Sterile Surgical Pads, Cushion C... | Jun 22, 2022 |
| Z-1031-2022 | Class II | First Aid Kits containing acetaminophen under b... | Mar 2, 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.