Medline recalls two medical kits (Hysteroscopy Pack DYNJ48399C and Sling Pack DYNJ62849B) due to rescinded 510(k) regulatory clearances. Affected units include specific lot numbers and model numbers.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling two medical kits: a Hysteroscopy Pack (model DYNJ48399C) and a Sling Pack (model DYNJ62849B). The recall is due to regulatory clearances for certain medical components being rescinded, which could affect safety and compliance.
The 510(k) regulatory clearances for specific medical components like Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded. This means the devices may no longer meet safety and regulatory standards, potentially leading to unsafe use in medical procedures.
Healthcare providers using these kits for medical procedures are likely affected. The risk is highest for those using the kits in clinical settings where precise medical devices are critical.
Check for model numbers DYNJ48399C (Hysteroscopy Pack) and DYNJ62849B (Sling Pack). Affected units include lot numbers 24CBU779 and 24BBS275.
Identify the model number on the kit to determine if it is DYNJ48399C or DYNJ62849B.
Check the lot number on the kit; affected units have lot numbers 24CBU779 or 24BBS275.
The 510(k) regulatory clearances for certain medical components have been rescinded, which could affect safety and compliance.
The Hysteroscopy Pack model DYNJ48399C and Sling Pack model DYNJ62849B are affected.
Lot numbers 24CBU779 for the Hysteroscopy Pack and 24BBS275 for the Sling Pack are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1847-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1847-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
+ 1 more story
