The Recall Desk
SevereFDA (Devices)·Z-1728-2026·Announced 2026-04-15

Medline robotic surgery packs recalled over syringe adaptor unwinding risk

Medline is recalling Robotic Pack and Uro/Gen Robotic Pack convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. This action covers the ROBOTIC PACK, Medline SKU DYNJ58475F, and the URO/GEN ROBOTIC PACK, Medline SKU DYNJ60803J. The action covers 439 kits.

Medline identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and the manifold. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, covering the United States nationwide including Puerto Rico, and Canada, the Netherlands, Australia, the Republic of Korea, Sri Lanka, Pakistan, Japan, the United Arab Emirates, Singapore and Slovakia. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the Medline SKU, UDI and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by Medline.

The recalled product

Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Manufacturer
Medline Industries, LP
Category
Medical Device — Robotic surgery pack
Hazard
Affected units
439

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline SKU # DYNJ58475F
  • UDI/DI each 10198459572388
  • UDI/DI case 40198459572389
  • Lot Number: 25LMK173
  • Medline SKU # DYNJ60803J
  • UDI/DI each 10195327138820
  • UDI/DI case 40195327138821
  • Lot Number: 26BMA268
  • Lot Number: 26AMH928
  • Lot Number: 25EMD876
  • Lot Number: 25EMA519
  • Lot Number: 25DMA846
  • Lot Number: 25BMH004
  • Lot Number: 25BMA218
  • Lot Number: 24KMI208
  • Lot Number: 24KMC007
  • Lot Number: 24JMD850
  • Lot Number: 24IMI939
  • Lot Number: 24EDB694
  • Lot Number: 24DDB793

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 19 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · disconnection risk

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