The Recall Desk
ModerateFDA (Devices)·Z-3120-2024·Announced 2024-09-18

Medline recalls surgical convenience kits in Class II recall

Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Class II medical device recall with no reported illness or injury. The specific hazard is not stated in available source material.

Plain-English summary

Medline Industries, LP is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners. The affected kits are labeled as AMB VITRECTOMY, AMB OCULOPLASTICS MUSC, AMB CUSTOM EYE, and CATARACT-30843. These kits contain various pack numbers with specific lot numbers identified for traceability.

The specific reason for this recall has not been disclosed in available FDA information. The recall has been classified as Class II, indicating a situation where use of the product may cause serious adverse health consequences or death.

The kits have been distributed worldwide, including to the United States, Canada, and Panama. Healthcare providers and facilities that received these kits should check their inventory against the provided lot numbers and pack numbers.

Consumers and healthcare providers who have these products should stop using them and contact Medline Industries for further instructions. Medical professionals should verify their inventory using the UDI codes and lot numbers provided in the recall notification.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Affected units
720

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)

  • a) DYNJ59921B: UDI/DI case 40195327037148
  • UDI/DI each 10195327037147
  • Lot Numbers: 23LBS025
  • 24ABY181
  • b) DYNJ59921BH: UDI/DI case 40195327037148
  • Lot Numbers: 23LBS025
  • c) DYNJ59923B: UDI/DI case 40195327043217
  • UDI/DI each 10195327043216
  • Lot Numbers: 23LBF664
  • 23LBS053
  • 24ABY182
  • d) DYNJ59923BH: UDI/DI case 40195327043217
  • Lot Numbers: 23LBF664
  • e) DYNJ59924B: UDI/DI case 40195327036967
  • UDI/DI each 10195327036966
  • Lot Numbers: 23LBD909
  • f) DYNJ59924BH: UDI/DI case 40195327036967
  • Lot Numbers: 23LBD909
  • g) DYNJVB91139: UDI/DI case 40195327607105
  • UDI/DI each 10195327607104

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 17 products in this recall →

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