The Recall Desk
HighFDA (Devices)·Z-2113-2024·Announced 2024-05-29

GMAX Non-Sterile Syringes Recalled for Unapproved Sizes and Configurations

GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.

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: FDA Class II medical device with potential risk due to being outside the scope of regulatory clearance. Although no adverse events have been reported, non-sterile syringes used outside their approved configuration pose a theoretical contamination and malfunction risk that warrants High severity per the rubric.

Plain-English summary

GMAX SYR 20ML/LL non-sterile syringes (Model TS2220L-M), manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. A total of 2,491,600 units across 19 lot codes are affected by this recall.

The syringes are being recalled because their sizes and configurations exceed the scope of devices cleared under the manufacturer's FDA 510(k) premarket notification. The 510(k) clearance only covers specific sizes and configurations; the recalled units fall outside this approved range.

The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Products were shipped to distribution points in Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.

Healthcare facilities, medical distributors, and individuals who received these syringes should discontinue use immediately. Contact the manufacturer for instructions on returning or destroying the affected product. Affected lot codes include SL21030106, SL21040105, SL21070105, SL21090106, SL21110105, SL21110202, SL21120105, SL22030106, SL22070109, SL22080103, SL22100207, SL22120205, SL23020205, SL23040205, SL23060304, SL23080307, SL23100407, SL23100301, and SL23120407.

The recalled product

Product
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Manufacturer
Jiangsu Shenli Medical Production Co., Ltd.
Category
Medical Device — Syringes / Injection Devices
Hazard
Affected units
2,491,600

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 (19)

  • Lot Code: LOT: SL21030106
  • SL21040105
  • SL21070105
  • SL21090106
  • SL21110105
  • SL21 110202
  • SL21120105
  • SL22030106
  • SL22070109
  • SL22080103
  • SL221002 07
  • SL22120205
  • SL23020205
  • SL23040205
  • SL23060304
  • SL23080307
  • SL23100407
  • SL23100301
  • SL23120407

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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