Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
Medical device recall Z-2022-2026. Published in FDA’s Enforcement Report on May 6, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 21288 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q; 5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L; 6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J; 7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K; 8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K; 9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K; 10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M; 11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q; 12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C; 13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G; 14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D; 15. FUNCTIONAL SINUS ENDOSCOPY, Medline Kit Number/SKU DYNJ40406A; 16. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645C; 17. FREE FLAP B PACK, Medline Kit Number/SKU DYNJ40648G; 18. MINOR ENT PACK, Medline Kit Number/SKU DYNJ50808A; 19. SINUS ENDOSCOPY PACK-LF, Medline Kit Number/SKU DYNJ52062; 20. LAP PACK, Medline Kit Number/SKU DYNJ52116B; 21. LAP PACK, Medline Kit Number/SKU DYNJ52116C; 22. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719C; 23. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719D; 24. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917I; 25. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917J; 26. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917K; 27. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917L; 28. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917N; 29. LARYNGOSCOPY WEST PACK, Medline Kit Number/SKU DYNJ58324A; 30. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558A; 31. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558B; 32. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213; 33. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213D; 34. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213G; 35. EENT PACK, Medline Kit Number/SKU DYNJ68366B; 36. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447; 37. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447A; 38. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447B; 39. UNIVERSITY DISC PACK, Medline Kit Number/SKU DYNJ69824; 40. MAJOR PACK, Medline Kit Number/SKU DYNJ81325; 41. MAJOR PACK, Medline Kit Number/SKU DYNJ81325A; 42. MAJOR PACK, Medline Kit Number/SKU DYNJ81325B; 43. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751; 44. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751A; 45. FLAP PACK, Medline Kit Number/SKU DYNJ85359; 46. ENDO PACK, Medline Kit Number/SKU DYNJ86125; 47. ENDO PACK, Medline Kit Number/SKU DYNJ86125A; 48. ENT PACK, Medline Kit Number/SKU DYNJ88448; 49. MAJOR BACK PACK, Medline Kit Number/SKU DYNJ88470; 50. UROLOGY DAVINCI, Medline Kit Number/SKU DYNJ901572O; 51. LARYNGOSCOPY/BRONCH, Medline Kit Number/SKU DYNJ902985F; 52. KIT FREE FLAP MOSES, Medline Kit Number/SKU DYNJ905366B; 53. FLAP, Medline Kit Number/SKU DYNJ907076C; 54. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165; 55. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165A; 56. ENDOSCOPY, Medline Kit Number/SKU DYNJ909512; 57. DIEP FLAP, Medline Kit Number/SKU DYNJ910120A; 58. DIEP BREAST, Medline Kit Number/SKU DYNJ911086; 59. WILLIAMS GENERAL, Medline Kit Number/SKU DYNJ940735F; 60. ROBOTIC LAP PROSTATE PACK CHS, Medline Kit Number/SKU DYNJT3101; 61. CUH FLAP ACCESSORY PACK, Medline Kit Number/SKU DYNJT3243.
21288 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit…
Every code shown here, 1,998 characters
Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25BDA328; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDB408; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDA607; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23HMH658; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23GMD341; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23EMB793; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23CMG372; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23BMI499; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22JMF967; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22EMC648; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22CMD889; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24EMH897; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24DMF264; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24BMJ904; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24AMH650; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case…
FDA’s list runs to 53,401 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 19, 2026.
- FDA classified it on Apr 30, 2026.
- FDA’s Enforcement Report published it on May 6, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 53,401 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.