Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1
Medical device recall Z-0720-2025. Published in FDA’s Enforcement Report on Jan 1, 2025.
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 Jan 1, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 6467 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?
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370
6467 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: CDS982901F, 10889942216970 (each), 40889942216971 (case), Lot Numbers: 23HBQ152; UDI-DI: DYNJ17493G, 10195327224424 (each), 40195327224425 (case), Lot Numbers: 23GBW775; UDI-DI: DYNJ33520A, 10884389851333 (each), 40884389851334…
Every code shown here, 1,998 characters
UDI-DI: CDS982901F, 10889942216970 (each), 40889942216971 (case), Lot Numbers: 23HBQ152; UDI-DI: DYNJ17493G, 10195327224424 (each), 40195327224425 (case), Lot Numbers: 23GBW775; UDI-DI: DYNJ33520A, 10884389851333 (each), 40884389851334 (case), Lot Numbers: 23HDB834; UDI-DI: DYNJ44845G, 10889942712311 (each), 40889942712312 (case), Lot Numbers: 23HBF195; UDI-DI: DYNJ48330B, 10195327113506 (each), 40195327113507 (case), Lot Numbers: 23HBO622; UDI-DI: DYNJ50572, 10889942008476 (each), 40889942008477 (case), Lot Numbers: 23GBR940; UDI-DI: DYNJ53573A, 10193489201635 (each), 40193489201636 (case), Lot Numbers: 23GBS356; UDI-DI: DYNJ58856A, 10193489750263 (each), 40193489750264 (case), Lot Numbers: 23HBO870; UDI-DI: DYNJ60111A, 10193489246995 (each), 40193489246996 (case), Lot Numbers: 21JMB783 21HMF433 21GMD178 21FMC923 20IMB575; UDI-DI: DYNJ60111B, 10195327527617 (each), 40195327527618 (case), Lot Numbers: 24HMC974 24GMA899 24FMB079 24EMC108 24DMD791 24CMG320; UDI-DI: DYNJ63052C, 10195327101312 (each), 40195327101313 (case), Lot Numbers: 22KME394 22KMA630 22JMD852 22GMG160 22EMG974 22DMF954 22CMC565; UDI-DI: DYNJ64256D, 10195327452773 (each), 40195327452774 (case), Lot Numbers: 23HBA766; UDI-DI: DYNJ64509B, 10195327323745 (each), 40195327323746 (case), Lot Numbers: 23HBC092; UDI-DI: DYNJ65644, 10193489283204 (each), 40193489283205 (case), Lot Numbers: 23HBA753; UDI-DI: DYNJ66749, 10193489375947 (each), 40193489375948 (case), Lot Numbers: 21ABT938 21ABO570 20JBS998 20HBM389; UDI-DI: DYNJ67423A, 10195327163402 (each), 40195327163403 (case), Lot Numbers: 24DLA092 24BLA235 23KLA058 23ILB043 23ILA503 23HLB296 23HLB011 23FLA068 23DLA463 23DLA185 23BLA617 22LLA582 22KLA652 22HLA029 22GLA884; UDI-DI: DYNJ67423B, 10195327686871 (each), 40195327686872 (case), Lot Numbers: 24GLB018 24FLA258 24ELA763 24DLA759; UDI-DI: DYNJ68102B, 10195327699369 (each), 40195327699360 (case), Lot Numbers: 24IBB348 24GBB791 24EBA114; UDI-DI: DYNJ80526B, 10195327211059 (each), 40195327211050 (case),…
FDA’s list runs to 4,195 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.
US Nationwide. Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Nov 6, 2024.
- FDA classified it on Dec 20, 2024.
- FDA’s Enforcement Report published it on Jan 1, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 4,195 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.