Medline Industries, LP recalls Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYN…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Lot #
- 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case)
- Lot #
- 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case)
- Lot #
- 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case)
- Lot #
- 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot #
- 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case)
- Lot #
- 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case)
- Lot #
- 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case)
- Lot #
- 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case)
- Lot #
- 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case)
- Lot #
- 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case)
- Lot #
- 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case)
- Lot #
- 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case)
- Lot #
- 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case)
- Lot #
- 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case)
- Lot #
- 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case)
- Lot #
- 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case)
- Lot #
- 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case)
- Lot #
- 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case)
- Lot #
- 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case)
- Lot #
- 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case)
- Lot #
- 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case)
- Lot #
- 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case)
- Lot #
- 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case)
- Lot #
- 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case)
- Lot #
- 25FBF363
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What the firm is doing
Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail. The notice explained the issue with the device, potential harms, and requested the following: REQUIRED ACTION: 1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete the response form. Please list the quantity of affected product in inventory on the form. Even if there is no affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com 3. Upon receipt of the response form, the consignee account will receive over-labels to place on affected inventory, with instructions for the staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who transferred the affected product were directed to notify those to which the product was distributed or transferred. For contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2791-2026
- FDA device classification · OJHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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Medline Industries, LP recalls Medline medical convenience kits labeled as: NEURO PACK
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.
- Neurological Tray
- Process change control
