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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0720-2025
Related Recalls
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
MEDLINE INDUSTRIES, LP - Northfield
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.