CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Medline medical procedure convenience kits, labeled as: Sinus recalled
Medline Industries LP - Northfield is recalling Medline medical procedure convenience kits, labeled as: Sinus, distributed nationwide in the US. The recall was initiated on 6 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0720-2025
- FDA event ID
- 95806
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 6 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +44 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide. Canada.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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), Lot Numbers: 23HBF568; UDI-DI: DYNJ81280, 10195327102968 (each), 40195327102969 (case), Lot Numbers: 22HMF910; UDI-DI: DYNJ81420A, 10195327322601 (each), 40195327322602 (case), Lot Numbers: 24CBL416 23LBK136 23IBR308 23HBD265 23GBJ044 23FBK113 23EBN716 23BBQ143; UDI-DI: DYNJ81934, 10195327156817 (each), 40195327156818 (case), Lot Numbers: 23EBG024 23BBC727 22JBJ632 22HBH399; UDI-DI: DYNJ81934A, 10195327413019 (each), 40195327413010 (case), Lot Numbers: 24DBK564 24DBB486 24CBG998 24BBV700 24ABD320 23HBO084 23GBG012; UDI-DI: DYNJ83679A, 10195327459727 (each), 40195327459728 (case), Lot Numbers: 24HBP441 24GBF665 24BBO428 23LBS373 23JBD663 23IBN314; UDI-DI: DYNJ84270, 10195327349103 (each), 40195327349104 (case), Lot Numbers: 23GBC274; UDI-DI: DYNJ85422, 10195327499716 (each), 40195327499717 (case), Lot Numbers: 24FDA925 24ADB100; UDI-DI: DYNJ901299A, 10889942010349 (each), 40889942010340 (case), Lot Numbers: 21FBC250 20JBO761 20IBH831 20FBM501; UDI-DI: DYNJ901299B, 10193489923384 (each), 40193489923385 (case), Lot Numbers: 22FBU440 22OBC118 22OBC120 22ABA377 21JBJ197 21IBM868 21GBO441; UDI-DI: DYNJ905685D, 10198459024139 (each), 40198459024130 (case), Lot Numbers: 24IDB382; UDI-DI: DYNJ906474C, 10195327221355 (each), 40195327221356 (case), Lot Numbers: 24HDA228 24EDA811 24DDB542 23LDB493 23GDA771 23DDA732 22IDB976; UDI-DI: DYNJ906839A, 10195327092528 (each), 40195327092529 (case), Lot Numbers: 22JMB394; UDI-DI: DYNJ908545A, 10195327384166 (each), 40195327384167 (case), Lot Numbers: 23JBV681; UDI-DI: DYNJ908545B, 10195327593124 (each), 40195327593125 (case), Lot Numbers: 24HBI988 24FBS776 24FBA297 24ABT058; UDI-DI: DYNJ909128A, 10195327326739 (each), 40195327326730 (case), Lot Numbers: 23EBD903 23DBD851; UDI-DI: DYNJ909128C, 10195327458416 (each), 40195327458417 (case), Lot Numbers: 23JBO251 23HBI313; UDI-DI: DYNJ909128D, 10195327516321 (each), 40195327516322 (case), Lot Numbers: 24EBC023 24CBK211 24BBM816 24ABR742 23LBQ695 23LBM416; UDI-DI: DYNJ909128F, 10198459055256 (each), 40198459055257 (case), Lot Numbers: 24HBV054 24GBN495; UDI-DI: DYNJ909370, 10195327319038 (each), 40195327319039 (case), Lot Numbers: 24BMA818 24AMG256 23LMF420 23LMB722 23LMA458 23CME287;
Where was it sold?
US Nationwide. Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 95806This product is part of a recall event; the main page for the event is KIT,Spine LH Convenience kit recalled by MEDLINE INDUSTRIES, LP.
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