Class II FDA device recall · Z-0909-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Why it was recalled

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Catalog Number SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number  21J2883        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  24C0535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1029        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1029        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  23F1437        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  23F1437        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  24C0535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  24C0535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18E1332        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18H2278        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  24C0535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18J2582        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18M3535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18M3535        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19A0124        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19E1525        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19K3308        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  N/A            ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19K3308        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19C0888        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  18H2278        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19C0888        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19A0124        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  19B0560        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number  22D1028        ;  Catalog Number SEN15SERM5, UDI/DI 10195594423469 (EA)50195594423467 (CS), Lot Number  5533336        ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J3987C         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J43U74         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J46A98         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J46C04         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J72P53         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J8393W         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J6050H         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  J86T82         ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  5140356        ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  5891304        ;  Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number  6264567        ;  Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number  6928759        ;  Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number  7163104        ;  Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number  7331342        ;  Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number  7332908        ;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Recall record

Recalling firm: Cardinal Health 200, LLC
Product type: Devices
Recall number: Z-0909-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Waukegan, IL
Recall initiated: 2024-11-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0909-2025 · Source: openFDA enforcement.