FDA recall, , Moderate risk
Medline Hudson RCI Medium Concentration Oxygen Masks
Medline Hudson RCI Medium Concentration Oxygen Masks can have tubing disconnect, delaying patient care and causing shortness of breath.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled Medline Hudson RCI Medium Concentration Oxygen Masks after receiving multiple complaints regarding tubing disconnecting from the oxygen mask. If the issue occurs during use, it may lead to a delay in patient care and the patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
The recall began on November 21, 2025, and was added to the FDA's Enforcement Report on January 8, 2026. The products were distributed nationwide in the US and worldwide to Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline Hudson RCI Medium Concentration Oxygen Masks
- UDI-DI
- 00888277446727
- 40888277446725
- 10197344011575
- 20197344011572
- 10197344011544
- 20197344011541
- 10197344009626
- 20197344009623
- 10197344010646
- 20197344010643
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98125
- Recall number
- Z-1035-2026
- Quantity recalled
- 1,611,081 eaches
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
