Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951
Medical device recall Z-0908-2025. Published in FDA’s Enforcement Report on Jan 22, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 512,786 total units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953; 11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954; 12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955; 13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956; 14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957; 15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958; 16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959; 17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A; 18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C; 19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F; 20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G; 21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1; 22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2; 23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB; 24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC; 25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD; 26) DIEP PACK,Catalog Number SBA11DPS10; 27) DIEP PACK,Catalog Number SBA11DPS11; 28) DIEP PACK,Catalog Number SBA11DPS12; 29) DIEP PACK,Catalog Number SBA11DPS13; 30) DIEP PACK,Catalog Number SBA11DPS14; 31) DIEP PACK,Catalog Number SBA11DPS15; 32) DIEP PACK,Catalog Number SBA11DPS16; 33) DIEP PACK,Catalog Number SBA11DPS17; 34) DIEP PACK,Catalog Number SBA11DPS18; 35) DIEP PACK,Catalog Number SBA11DPS19; 36) DIEP PACK,Catalog Number SBA11DPS20; 37) DIEP PACK,Catalog Number SBA11DPS21; 38) DIEP PACK,Catalog Number SBA11DPS22; 39) DIEP PACK,Catalog Number SBA11DPSB4; 40) DIEP PACK,Catalog Number SBA11DPSB5; 41) DIEP PACK,Catalog Number SBA11DPSB6; 42) DIEP PACK,Catalog Number SBA11DPSB7; 43) DIEP PACK,Catalog Number SBA11DPSB8; 44) DIEP PACK,Catalog Number SBA11DPSB9; 45) DIEP PACK,Catalog Number SBA11DPSBD; 46) DIEP PACK,Catalog Number SBA11DPSBE; 47) DIEP PACK,Catalog Number SBA11DPSBF; 48) DIEP PACK,Catalog Number SBA11DPSBG; 49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1; 50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2; 51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3; 52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4; 53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5; 54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6; 55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB; 56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC; 57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD; 58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE; 59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10; 60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11; 61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12; 62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13; 63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo
512,786 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052…
Every code shown here, 1,999 characters
Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671K ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671M ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671P ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number J86T83 ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number 5405627 ; Catalog Number PWHDOT95F, UDI/DI…
FDA’s list runs to 78,092 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 8, 2024.
- FDA classified it on Jan 15, 2025.
- FDA’s Enforcement Report published it on Jan 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health 200, LLC, of Waukegan, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 78,092 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.