Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medli
Summary
The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .
Details
Source
Device Recall
External ID
Z-2020-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 1294 kits
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2020-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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