Class II FDA device recall · Z-0917-2025

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) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;

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 PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U76         ;  Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U77         ;  Catalog Number PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS), Lot Number  J34J42         ;  Catalog Number PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS), Lot Number  J8124C         ;  Catalog Number PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS), Lot Number  5478802        ;  Catalog Number PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS), Lot Number  6702010        ;  Catalog Number PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS), Lot Number  6928766        ;  Catalog Number PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS), Lot Number  7280108        ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J53W73         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679J         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J6050D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J74A31         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6596396        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J8671P         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6050H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5135997        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5533333        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J70X17         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664099        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5140345        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664103        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891308        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891307        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6367H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6025791        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  L00302         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6560945        ;  Catalog Number PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS), Lot Number  6702009        ;  Catalog Number PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS), Lot Number  6928770        ;  Catalog Number SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS), Lot Number  6914944        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6022130        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6702009        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806115        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806114        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928759        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928766        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280107        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  5              ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280109        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7331341        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332916        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928772        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332907        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  7332905        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS), Lot Number  J8692Y         ;  Catalog Number SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J37U06         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J31U58         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J46C00         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J4952D         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679A         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J53W68         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  N/A            ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679K         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J84K02         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  2300125464     ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6563992        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928758        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928759        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928764        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7163103        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7280105        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332904        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332918        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  J86T81         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5135984        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5140348        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5405626        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5533334        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5664098        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5747232        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891307        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891305        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891313        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022133        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022130        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6264567        ;

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-0917-2025
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-0917-2025 · Source: openFDA enforcement.