The Recall Desk
HighFDA (Devices)·Z-2119-2024·Announced 2024-05-29

GMAX Non-Sterile Syringes Recalled for Regulatory Non-Compliance

GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of non-sterile syringes that fall outside the manufacturer's cleared device specifications. Non-sterile medical injection devices pose an inherent risk of infection and contamination. Although no reported illnesses or injuries are documented in the source, this qualifies as a risk-of-harm product per the severity rubric, justifying a High rating.

Plain-English summary

GMAX SYR 20ML/LS syringes (model TS2220S-M), manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled because they do not conform to the device specifications that the FDA had cleared the manufacturer to distribute under its 510(k) submission.

Approximately 62,000 units are affected by this recall. The affected lot codes are: SL21030110, SL21040106, SL21070106, SL21090107, SL21110106, SL21120106, SL21110308, SL22030107, SL22080104, SL22100208, SL23020206, SL23040206, SL23080308, and SL23100408. The non-sterile syringes without needles were distributed throughout the United States in California, Florida, Georgia, Illinois, Tennessee, and Virginia, shipped through ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.

Use of medical devices that do not meet their FDA-approved specifications could create safety concerns. If you have received or used these syringes, discontinue use immediately and contact your supplier or the manufacturer for guidance on return or replacement.

Healthcare facilities and distributors that received these syringes should check their inventory against the provided lot codes and remove affected units from service to prevent further distribution.

The recalled product

Product
Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Manufacturer
Jiangsu Shenli Medical Production Co., Ltd.
Category
Medical Device — Injection Syringes
Hazard
Affected units
62,000

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 (14)

  • Lot Code: LOT: SL21030110
  • SL21040106
  • SL21070106
  • SL21090107
  • SL21110106
  • SL21 120106
  • SL21110308
  • SL22030107
  • SL22080104
  • SL22100208
  • SL230202 06
  • SL23040206
  • SL23080308
  • SL23100408

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 87 recalled by Jiangsu Shenli Medical Production Co., Ltd. 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 87 products in this recall →

Related recalls

Same manufacturer · Jiangsu Shenli Medical Production Co., Ltd.

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Same hazard · non sterile

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