Medline Procedure Convenience Kits (Medline) – Endotoxin Level (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 ENDOSCOP
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch 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), 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
Products Sold
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;
MEDLINE INDUSTRIES, LP Northfield is recalling Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NA due to Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026