CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

Cardinal Health Presource Kits: Kit,Maxillofacial,Presbyterian recalled

Cardinal Health 200 is recalling Cardinal Health Presource Kits: Kit,Maxillofacial,Presbyterian, 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

Lot, batch or date codes1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6022K ; 12) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6372Z ; 13) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J7708T ; 14) PWV2MF10W, UDI-DI:10888439693645 (each) 50888439693643 (case), Lot Number: J8241D ; 15) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K11 ; 16) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K10 ; 17) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: J65K19 ; 18) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 5775812 ; 19) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6116189 ; 20) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6251076 ; 21) PWV2MF111, UDI-DI:10195594634957 (each) 50195594634955 (case), Lot Number: 5858469 ; 22) PWV2MF112, UDI-DI:10195594711177 (each) 50195594711175 (case), Lot Number: 6022146 ; 23) PWV2MFCP2, UDI-DI:10197106368718 (each) 50197106368716 (case), Lot Number: 6788690 ; 24) PWV2MFCP3, UDI-DI:10197106738399 (each) 50197106738397 (case), Lot Number: 7333448 ; 25) PWV2MFCP4, UDI-DI:10197106784167 (each) 50197106784165 (case), Lot Number: 7360541 ; 26) PWV2MFCPA, UDI-DI:10197106143469 (each) 50197106143467 (case), Lot Number: 6701855 ; 27) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6702040 ; 28) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6788692 ; 29) PWV2MFCPC, UDI-DI:10197106425701 (each) 50197106425709 (case), Lot Number: 6788692 ; 30) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160517 ; 31) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160540 ; 32) PWV2MFCPE, UDI-DI:10197106532461 (each) 50197106532469 (case), Lot Number: 7287574 ; 33) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287574 ; 34) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287577 ; 35) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7331480 ;

Quantity recalled973,785 total units

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-1130-2025
FDA event ID: 95947
Recalling firm: Cardinal Health 200, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Nov 2024
FDA classified: 10 Feb 2025
Reported: 19 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Nov 2024	Recall initiated by company
10 Feb 2025	Classified by FDA	+94 days
19 Feb 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for 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,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF

Where it was distributed

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

Nationwide

Questions about this recall

Is Cardinal Health Presource Kits: Kit,Maxillofacial,Presbyterian recalled?

Yes. Cardinal Health 200 recalled Cardinal Health Presource Kits: Kit,Maxillofacial,Presbyterian on 8 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-1130-2025.

Why was it recalled?

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

Which lots are affected?

1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6022K ; 12) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6372Z ; 13) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J7708T ; 14) PWV2MF10W, UDI-DI:10888439693645 (each) 50888439693643 (case), Lot Number: J8241D ; 15) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K11 ; 16) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K10 ; 17) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: J65K19 ; 18) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 5775812 ; 19) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6116189 ; 20) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6251076 ; 21) PWV2MF111, UDI-DI:10195594634957 (each) 50195594634955 (case), Lot Number: 5858469 ; 22) PWV2MF112, UDI-DI:10195594711177 (each) 50195594711175 (case), Lot Number: 6022146 ; 23) PWV2MFCP2, UDI-DI:10197106368718 (each) 50197106368716 (case), Lot Number: 6788690 ; 24) PWV2MFCP3, UDI-DI:10197106738399 (each) 50197106738397 (case), Lot Number: 7333448 ; 25) PWV2MFCP4, UDI-DI:10197106784167 (each) 50197106784165 (case), Lot Number: 7360541 ; 26) PWV2MFCPA, UDI-DI:10197106143469 (each) 50197106143467 (case), Lot Number: 6701855 ; 27) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6702040 ; 28) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6788692 ; 29) PWV2MFCPC, UDI-DI:10197106425701 (each) 50197106425709 (case), Lot Number: 6788692 ; 30) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160517 ; 31) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160540 ; 32) PWV2MFCPE, UDI-DI:10197106532461 (each) 50197106532469 (case), Lot Number: 7287574 ; 33) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287574 ; 34) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287577 ; 35) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7331480 ;

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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