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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Industries, LP.

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 Class 2 Device Recall Medline Industries, LP.see related information
Date Initiated by FirmNovember 21, 2025
Date PostedJanuary 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1035-2026
Recall Event ID 98125
Product Classification Mask, oxygen - Product Code BYG
ProductMedline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
Code Information UDI: 1041CE 00888277446727 (ea) 40888277446725 (case); HUD1035 10197344011575 (ea) 20197344011572 (case); HUD1042 10197344011544 (ea) 20197344011541 (case); HUD1930 10197344009626 (ea) 20197344009623 (case); HUDRHO41U 10197344010646 (ea) 20197344010643 (case) Lots: 24DOA701 25EOA321 25EOA589 25EOA724 25EOA730 25EOA781 25EOA857 25FOA151 25FOA152 25FOA153 25FOA206 25FOA218 25FOA219 25FOA220 25FOA221 25FOA275 25FOA287 25FOA288 25FOA418 25FOA419 25FOA420 25FOA421 25FOA422 25FOA514 25FOA515 25FOA524 25FOA525 25FOA551 25FOA552 25FOA553 25FOA556 25FOA557 25FOA642 25FOA643 25FOA647 25FOA648 25FOA649 25FOA650 25FOA722 25FOA740 25FOA864 25FOA865 25FOA866 25GOA055 25GOA065 25GOA066 25GOA077 25GOA078 25GOA096 25GOA098 25GOA190 25GOA210 25GOA211 25GOA328 25GOA363 25GOA364 25GOA365 25GOA366 25GOA367 25GOA437 25GOA445 25GOA446 25GOA561 25GOA562 25GOA563 25GOA564 25GOA565 25GOA640 25GOA641 25GOA648 25GOA655 25GOA735 25GOA736 25GOA756 25GOA757 25GOA758 25GOA759 25GOA760 25GOA761 25GOA766 25GOA830 25GOA994 25GOA998 25HOA009 25HOA011 25HOA017 25HOA018 25HOA019 25HOA020 25HOA021 25HOA022 25HOA060 25HOA061 25HOA071 25HOA247 25HOA249 25HOA252 25HOA253 25HOA254 25HOA255 25HOA256 25HOA316 25HOA335 25HOA372 25HOA373 25HOA452 25HOA455 25HOA456 25HOA457 25HOA458 25HOA459 25HOA460 25HOA462 25HOA469 25HOA474 25HOA478 25HOA532 25HOA533 25HOA538 25HOA629 25HOA630 25HOA631 25HOA632 25HOA633 25HOA639 25HOA644 25HOA723 25HOA724 25HOA734 25HOA829 25HOA830 25HOA831 25HOA832 25HOA833 25HOA853 25IOA020 25IOA021 25IOA090 25IOA097 25IOA163 25IOA164 25IOA165 25IOA166 25IOA244 25IOA246 25IOA247 25IOA253 25IOA363 25IOA364 25IOA365 25IOA366 25IOA367 25IOA368 25IOA369 25IOA410 25IOA438 25IOA439 25IOA520 25IOA521 25IOA522 25IOA523 25IOA524 25IOA525 25IOA526 25IOA527 25IOA637 25IOA638 25IOA668 25IOA682 25IOA683 25IOA684 25IOA685 25IOA686 25IOA687 25IOA688 25IOA743 25IOA787 25JOA027 25JOA032 25JOA047 25JOA048 25JOA049 25JOA050 25JOA051 25JOA052 25JOA053 25JOA179 25JOA213 25JOA215 25JOA243 25JOA246 25JOA247 25JOA248 25JOA249 25JOA250 25JOA251 25JOA252 25JOA253 25JOA386 25JOA430 25JOA467 25JOA561 25JOA562 25JOA563 25JOA564 25JOA579 25JOA670 25JOA675 25JOA757 25JOA758 25JOA760 25JOA762 25JOA763 25JOA778 25JOA779 25JOA780 25JOA832 25JOA835 25JOA856 25JOA940 25JOA941 25JOA942 25KOA050 25KOA051
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn November 21, 2025, the firm notified customers via Urgent Medical Device Recall letter. Customers were instructed to destroy affected product on hand. No product is being returned to Medline. For kits, Medline instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply.
Quantity in Commerce1,611,081 eaches
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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