Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE ...
FDA Device Recall #Z-2020-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-2020-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1294 kits |
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.
Reason for Recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22EBQ566; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22OBM500; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22BBH011; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22ABF773; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21KBM498; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21JBJ185; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21IBM809; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21IBE910; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21HBF657; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21FBQ527; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21EBC912; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349, Lot Number: 26BBJ475; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349, Lot Number: 25LBD824; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21IME243; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21GMD919; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21EMB698; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21CMB708; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21BMB155; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 22FDA247; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 22BDB470; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21KDB891; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21IDA884; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21DDB913; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21DDB294; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21FBB400; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21EBN493; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21DBP964; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21OBA488; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21ABF008; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23KBP837; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23GBS485; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23FBJ867; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23EBD035; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23BBB609; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 22FBW392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 22OBB247; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25KBH559; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25HBT244; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25HBQ392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25DBF266; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24LBN800; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24KBJ090; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24GBY270; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24EBA930; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24BBU360.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
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.