Medline recalls specific kits with rescinded 510(k) clearances for control syringes and guidewires. Affected units include model DYNJ44813D with certain lot numbers. No remedy provided in recall notice.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling specific kits containing control syringes and guidewires due to rescinded 510(k) regulatory clearances. This means the products may not meet safety standards and could pose risks if used without proper regulatory approval.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. This means the products no longer meet the safety standards required by the FDA for medical devices, potentially leading to unsafe use in clinical settings.
Healthcare professionals using Medline kits with model number DYNJ44813D and specific lot numbers are affected. Those in medical settings that use these kits are most at risk.
Check for model number DYNJ44813D on the kit. Look for specific lot numbers listed in the recall: 21CBJ477, 21GBE184, 21GBJ527, 21HBL388, 21IBT013, 21LBS718, 22BBD935, 22CBA262, 22FBM910, 22LBQ838, 23FBS838, 23IBD099, 23KBA057, 24ABJ743, 24EBG776, 24FBC225, 24IBW215, 24LBU055, 22HBG782, and 25DBP554.
Identify the model number and lot numbers on the kit to determine if it is affected by this recall.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded, meaning the products no longer meet FDA safety standards.
The recall notice does not provide a remedy, so affected users should check with Medline directly for guidance.
Look for model number DYNJ44813D with specific lot numbers listed in the recall: 21CBJ477, 21GBE184, 21GBJ527, 21HBL388, 21IBT013, 21LBS718, 22BBD935, 22CBA262, 22FBM910, 22LBQ838, 23FBS838, 23IBD099, 23KBA057, 24ABJ743, 24EBG776, 24FBC225, 24IBW215, 24LBU055, 22HBG782, and 25DBP554.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1845-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1845-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
