CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery recalled
Cardinal Health 200 is recalling Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery, distributed nationwide in the US. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0911-2025
- FDA event ID
- 95722
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2024
- FDA classified
- 15 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 8 Nov 2024 | Recall initiated by company | |
| 15 Jan 2025 | Classified by FDA | +68 days |
| 22 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Questions about this recall
Is Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery recalled?
Yes. Cardinal Health 200 recalled Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery on 8 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0911-2025.
Why was it recalled?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Which lots are affected?
Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J1896M ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J3987C ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J43U76 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J46C02 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J4952G ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J74A30 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8064Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8123Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J84K03 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 24C0657 ;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
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