Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 6, 2026
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
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-…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP recalled Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: … - a moderate-severity action.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: … was recalled by Medline Industries, LP in May 6, 2026. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medli…. Check the official notice for the remedy. Verify recall #Z-2022-2026 with the FDA Devices before acting.
The recall
Medline Industries, LP issued this moderate-severity FDA Devices recall-During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medli….
- Moderate
- severity level
- Class II
- classification
- May 6, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2022-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2022-2026) was formally reported on May 6, 2026, with the manufacturer initiating the action on March 19, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 21288 kits.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices and 2 from Medline Industries, LP - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21288 kits
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2022-2026 |
| Date reported | May 6, 2026 |
| Date initiated | March 19, 2026 |
| Recalling firm | Medline Industries, LP |
| Firm location | Northfield, IL |
| Affected scope | 21288 kits |
| Distribution | Worldwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2022-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Medline Industries, LP. Units affected: 21288 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2026. Severity: Moderate. Recall number: Z-2022-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2022-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 6, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.