Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW
Medical device recall Z-1132-2025. Published in FDA’s Enforcement Report on Feb 19, 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 Feb 19, 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
- 973,785 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 for 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,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC2 54) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCB 55) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCC 56) ENDO SSOP PACK, Catalog Number:SBA23ENPCD 57) L T P PACK, Catalog Number:SEN11LTCH3 58) L T P PACK, Catalog Number:SEN11LTCH4 59) ENT PACK, Catalog Number:SEN12NSHHT 60) ENT PACK, Catalog Number:SEN12NSHHU 61) ENT, Catalog Number:SEN13ENRU5 62) ENT, Catalog Number:SEN13ENRU6 63) ENT, Catalog Number:SEN13ENRUH 64) NASAL PACK, Catalog Number:SEN13NSCOH 65) NASAL PACK, Catalog Number:SEN13NSCOI 66) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT3 67) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT4 68) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNTJ 69) SINUS ENT PACK, Catalog Number:SEN13SNNT1 70) SINUS ENT PACK, Catalog Number:SEN13SNNT2 71) SINUS ENT PACK, Catalog Number:SEN13SNNT3 72) STERILE SINUS ENT PACK, Catalog Number:SEN13SNNTL 73) ENT PACK, Catalog Number:SEN21EPHO1 74) ENT PACK, Catalog Number:SEN21EPHO2 75) ENT PACK, Catalog Number:SEN21EPHO3 76) ENT PACK, Cata
973,785 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044…
Every code shown here, 1,996 characters
1) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044 (case), Lot Number: 5664108 ; 4) PE29NSFG7, UDI-DI:10197106511206 (each) 50197106511204 (case), Lot Number: 7280115 ; 5) PE29NSFG8, UDI-DI:10197106535981 (each) 50197106535989 (case), Lot Number: 7320240 ; 6) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J3593N ; 7) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J46C07 ; 8) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J4952P ; 9) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679N ; 10) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679T ; 11) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J7905H ; 12) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6701854 ; 13) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7005491 ; 14) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7266056 ; 15) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7280114 ; 16) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J84K06 ; 17) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693H ; 18) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693K ; 19) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J6368Z ; 20) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 21) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 22) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5841390 ; 23) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319…
FDA’s list runs to 145,288 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 Feb 10, 2025.
- FDA’s Enforcement Report published it on Feb 19, 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 145,288 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.