Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICRO... — FDA record Z-0916-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Num...
- Reason
- Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 512,786 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0916-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J34J41 ; Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J43U77 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952G ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J53W73 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952H ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J6050F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J74A27 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7963D ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7905F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J84K02 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J8692Y ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J86T82 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 20166041-3014 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 5138318 ; Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number 7331471 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7265882 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7280085 ; Catalog Number PN33MSOCI, UDI/DI 10197106586525 (EA)50197106586523 (CS), Lot Number 7265980 ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J9601U ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J96A01 ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number J9601W ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number 5138235 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number J70X03 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number 5664035 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J30T23 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4951J ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J53W36 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J7704A ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4678M ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4949U ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J6049W ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J79F27 ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J7704A ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J6786F ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number BCS725327015001; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5138322 ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5530911 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6748343 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6701994 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6563921 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6806107 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6487885 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7265878 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287503 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280085 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331468 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331303 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7102720 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6264449 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6986975 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7005435 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6907766 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7122068 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7284052 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280047 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280048 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287482 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280050 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332804 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5618930 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5891287 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6487884 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6485582 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6748342 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6264449 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6806107 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6701970 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7110268 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7265878 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7122068 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7287457 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7360338 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332852 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701996 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6775018 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6806107 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265879 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280085 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331306 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7349669 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701995 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701994 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7045815 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280047 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701942 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7058621 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7005446 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7286183 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280059 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280048 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331284 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332832 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701957 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6568661 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6563990 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6487901 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6914944 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928766 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928764 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7127056 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7160537 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928773 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7163104 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280110 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280109 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928772 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7332910 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 2407826964 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928770 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6345524 ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4951J ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4949R ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4877G ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J79H44 ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J7904N ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J8064U ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5775791 ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number J6049X ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5664045 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6279851 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Jan 15, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.