Medline medical procedure kits recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling 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 N. Reason: 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.
What is being recalled
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.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2020-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 19, 2026 |
| Reported | May 6, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1294 kits |
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