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RecallWatchMedical Device Safety
Class IIOngoingZ-2020-2026

Medline Industries, LP recalls Medline medical procedure kits

Medline Industries, LPNorthfield, IL, United StatesReported May 6, 2026 · 2 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 information

Lot #
22EBQ566; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
22OBM500; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
22BBH011; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
22ABF773; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21KBM498; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21JBJ185; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21IBM809; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21IBE910; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21HBF657; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Lot #
21FBQ527; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403
Show 35 more code fields
Lot #
21EBC912; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349
Lot #
26BBJ475; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349
Lot #
25LBD824; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164
Lot #
21IME243; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164
Lot #
21GMD919; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164
Lot #
21EMB698; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164
Lot #
21CMB708; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164
Lot #
21BMB155; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
22FDA247; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
22BDB470; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
21KDB891; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
21IDA884; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
21DDB913; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099
Lot #
21DDB294; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022
Lot #
21FBB400; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022
Lot #
21EBN493; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022
Lot #
21DBP964; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022
Lot #
21OBA488; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022
Lot #
21ABF008; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
23KBP837; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
23GBS485; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
23FBJ867; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
23EBD035; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
23BBB609; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
22FBW392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
22OBB247; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
25KBH559; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
25HBT244; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
25HBQ392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
25DBF266; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
24LBN800; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
24KBJ090; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
24GBY270; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
24EBA930; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646
Lot #
24BBU360

What the firm is doing

Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors must notify their customers and should include customer quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

Worldwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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