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FDA recall, , Moderate risk

Mahurkar Elite PASS Trays

Mahurkar Elite PASS Trays are missing the Tegaderm CHG dressing specified in product labeling.

Summary by Recall Canary from the FDA notice

What happened

Mozarc Medical US LLC of Mansfield, Massachusetts recalled Mahurkar Elite PASS Trays because the Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots. The FDA added the recall to its Enforcement Report on June 5, 2026, and the company began the recall on April 29, 2026. The affected products were distributed nationwide in the US.

More labeling error recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

Incomplete list: 40 of 85 lot codes shown.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Product details

    Mahurkar Elite PASS Trays;
    Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424);
    for acute hemodialysis, aphaeresis, and infusion.

    UDI-DI
    • 8888221413
    • 10884521788541
    • 241620022
    • 252020038
    • 8888222416
    • 10884521788602
    • 241690023
    • 241830147
    • 8888221416
    • 10884521788558
    • 251250041
    • 251740190
    • 252020039
    • 252090031
    • 253350256
    • 8888222420
    • 10884521788619
    • 251740186
    • 252510026
    • 253280016
    • 8888221420
    • 10884521788565
    • 241620407
    • 251950032
    • 8888222424
    • 10884521788626
    • 243040007
    • 8888221424
    • 10884521788572
    • 241200034
    • 251250039
    • 252020037
    • 8888221430
    • 10884521788589
    • 251250042
    • 8888233413
    • 10884521788718
    • 250310009
    • 8888233416
    • 10884521788725
    • 250350008
    • 250690152
    • 250690153
    • 250870012
    • 251010012
    • 251010013
    • 251320332
    • 251320333
    • 251390368
    • 251390369
    • 252580023
    • 8888233420
    • 10884521788732
    • 250870013
    • 250970052
    • 251320330
    • 251320331
    • 8888231420
    • 10884521788688
    • 241690216
    • 252020046
    • 252230023
    • 252580025
    • 8888233424
    • 10884521788749
    • 251740197
    • 252300054
    • 8888231424
    • 10884521788695
    • 251460351
    • 251740196
    • 252020045
    • 252230022
    • 252580024
    • 8888231430
    • 10884521788701
    • 252730009
    • 8888231413
    • 10884521788664
    • 250310010
    • 8888231416
    • 10884521788671
    • 252230021
    • 252510030
    • 252650294
    • 253140280
    • 8888213416
    • 10884521788527
    • 252300325
    • 8888211416
    • 10884521788435
    • 241060237
    • 250830187
    • 250900067
    • 251250037
    • 251430012
    • 252870014
    • 8888213420
    • 10884521788534
    • 252300051
    • 8888211420
    • 10884521788442
    • 241480021
    • 242390056
    • 250070005
    • 250310011
    • 250310012
    • 250760180
    • 250900066
    • 251250035
    • 251950034
    • 8888212413
    • 10884521788473
    • 242950260
    • 8888211413
    • 10884521788428
    • 252510028
    • 8888212416
    • 10884521788480
    • 243160028
    • 250760159
    • 251250036
    • 251320325
    • 8888212420
    • 10884521788497
    • 241350005
    • 250310006
    • 251740192
    • 252160037
    • 8888211424
    • 10884521788459
    • 250830185
    • 250830186
    • 250900298
    • 250900299
    • 251740179
    • 251950033
    Lot code
    • 241620022
    • 252020038
    • 241690023
    • 241830147
    • 251250041
    • 251740190
    • 252020039
    • 252090031
    • 253350256
    • 251740186
    • 252510026
    • 253280016
    • 241620407
    • 251950032
    • 243040007
    • 241200034
    • 251250039
    • 252020037
    • 251250042
    • 250310009
    • 250350008
    • 250690152
    • 250690153
    • 250870012
    • 251010012
    • 251010013
    • 251320332
    • 251320333
    • 251390368
    • 251390369
    • 252580023
    • 250870013
    • 250970052
    • 251320330
    • 251320331
    • 241690216
    • 252020046
    • 252230023
    • 252580025
    • 251740197

Recall details

Company began the recall
Sold in

US Nationwide distribution.

Company
Mozarc Medical US LLCMansfield, Massachusetts
Hazard
Labeling error
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
98891
Recall number
Z-2319-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

More medical device recalls

See all: More medical device recalls

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)