The Recall Desk
HighFDA (Devices)·Z-2081-2024·Announced 2024-05-29

Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing

Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.

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 for medical devices manufactured outside FDA-cleared specifications. This represents a risk-of-harm product, as defects in size or configuration could affect device performance during use.

Plain-English summary

Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 9,800 Medline non-sterile syringes without needles (model 91852, lot code 63722050001). The syringes were manufactured in sizes and configurations outside the range FDA-cleared under the manufacturer's 510(k) approval.

Medical devices manufactured outside their FDA-approved specifications may not perform as intended or may present unexpected hazards during use. While no injuries or illnesses have been reported, the dimensional and configuration discrepancies mean these syringes do not match what the FDA cleared for distribution.

The affected syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments routed through major U.S. ports including Los Angeles, Long Beach, Chicago, Miami, Savannah, Nashville, and Norfolk.

Customers and healthcare facilities that received these syringes should discontinue use and return them to Jiangsu Shenli Medical Production Co., Ltd. for replacement or refund. This is an FDA Class II recall.

The recalled product

Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
Manufacturer
Jiangsu Shenli Medical Production Co., Ltd.
Category
Medical Device — Syringes
Hazard
  • manufacturing-defect
  • out-of-specification

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 (1)

  • Lot Code: LOT: 63722050001

Distribution

Distributed nationwide across the United States.

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