Elevated site urgencyFDA Class II

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Agency
FDA Device
Recall date
Jun 11, 2026
Status
Ongoing
Company
Medline Industries, LP

1. What product was recalled?

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

Quantity: 155 kits

Code or lot text: Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.

LOT
Lot Number 25ABM761
LOT
Lot Number 25BBD107
LOT
Lot Number 25FBD534
LOT
Lot Number 25FBL772.
LOT
Lot Number 25FBR237
LOT
Medline Kit SKU DYNJ910103B
LOT
Medline Kit SKU DYNJ910961A
LOT
UDI/DI 10198459213342 (each) 40198459213343 (case)
LOT
UDI/DI 10198459346873 (each) 40198459346874 (case)
RECALL-NUMBER
Z-2788-2026

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.

Quantity: 398 kits

Code or lot text: Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.

LOT
Lot Number 24KBK487
LOT
Lot Number 24LBF187
LOT
Lot Number 25ABM992
LOT
Lot Number 25CBJ129
LOT
Lot Number 25DBI743
LOT
Lot Number 25FBU802.
LOT
Lot Number 25GBE239
LOT
Medline Kit SKU DYNJ39590O
LOT
Medline Kit SKU DYNJ88566
LOT
Medline Kit SKU DYNJ911535
LOT
UDI/DI 10198459179235 (each) 40198459179236 (case)
LOT
UDI/DI 10198459187780 (each) 40198459187781 (case)
LOT
UDI/DI 10198459377600 (each) 40198459377601 (case)
RECALL-NUMBER
Z-2789-2026

Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit

Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D: 7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C: 8) CRANIOTOMY Medline Kit SKU DYNJ910626: 9) NEURO SPINE Medline Kit SKU DYNJ910639.

Quantity: 1601 units

Code or lot text: Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363.

LOT
Lot Number 24KME109
LOT
Lot Number 24KMI926
LOT
Lot Number 24LBD222
LOT
Lot Number 24LBD661
LOT
Lot Number 24LBN441
LOT
Lot Number 24LBO744
LOT
Lot Number 24LMD416
LOT
Lot Number 25ABD265
LOT
Lot Number 25ABJ808
LOT
Lot Number 25ABL748
LOT
Lot Number 25ABM644
LOT
Lot Number 25ABP134
LOT
Lot Number 25BBS412
LOT
Lot Number 25BBT262
LOT
Lot Number 25BMB162
LOT
Lot Number 25BMI009
LOT
Lot Number 25CBD596
LOT
Lot Number 25CBO351
LOT
Lot Number 25CBO352
LOT
Lot Number 25DBC117
LOT
Lot Number 25DBE196
LOT
Lot Number 25DBS673
LOT
Lot Number 25DMB403
LOT
Lot Number 25DME458
LOT
Lot Number 25DMK347
LOT
Lot Number 25EBB260
LOT
Lot Number 25EBD582
LOT
Lot Number 25EBF179
LOT
Lot Number 25EBV317
LOT
Lot Number 25FBF363.
LOT
Lot Number 25FBL400
LOT
Lot Number 25FBM835
LOT
Lot Number 25FBS372
LOT
Lot Number 25FMA695
LOT
Lot Number 25FMC143
LOT
Medline Kit SKU DYNJ65065A
LOT
Medline Kit SKU DYNJ65066B
LOT
Medline Kit SKU DYNJ907718B
LOT
Medline Kit SKU DYNJ907732C
LOT
Medline Kit SKU DYNJ907984C
LOT
Medline Kit SKU DYNJ907987D
LOT
Medline Kit SKU DYNJ908413C
LOT
Medline Kit SKU DYNJ910626
LOT
Medline Kit SKU DYNJ910639
LOT
UDI/DI 10193489317183 (each) 40193489317184 (case)
LOT
UDI/DI 10193489317244 (each) 40193489317245 (case)
LOT
UDI/DI 10195327671723 (each) 40195327671724 (case)
LOT
UDI/DI 10195327671808 (each) 40195327671809 (case)
LOT
UDI/DI 10198459050671 (each) 40198459050672 (case)
LOT
UDI/DI 10198459050688 (each) 40198459050689 (case)
LOT
UDI/DI 10198459129889 (each) 40198459129880 (case)
LOT
UDI/DI 10198459130977 (each) 40198459130978 (case)
LOT
UDI/DI 10198459320491 (each) 40198459320492 (case)
RECALL-NUMBER
Z-2791-2026

Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P

Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P

Quantity: 574 kits

Code or lot text: UDI/DI 10198459098109 (each) 40198459098100 (case), Lot Numbers: 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296.

LOT
24KME164
LOT
25CMF838
LOT
25DMB248
LOT
25FMD941
LOT
25GMB662
LOT
25GMG296.
LOT
Lot Numbers: 25AMJ225
LOT
UDI/DI 10198459098109 (each) 40198459098100 (case)
RECALL-NUMBER
Z-2790-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Connecticut, Florida, Kansas, Massachusetts, Maryland, Montana, New York, Ohio, Oregon, Virginia

View source evidence for state distribution
  • Connecticut: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Florida: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Kansas: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Massachusetts: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Maryland: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Montana: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • New York: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Ohio: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Oregon: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
  • Virginia: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.