FDA Devices recall · Reported May 29, 2024
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co., Ltd. recalled Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Descri… - a critical-severity action.
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Descri… was recalled by Jiangsu Shenli Medical Production Co., Ltd. in May 29, 2024. Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).. Check the official notice for the remedy. Verify recall details with the FDA Devices before acting.
The recall
Jiangsu Shenli Medical Production Co., Ltd. issued this critical-severity FDA Devices recall-Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)..
- Critical
- severity level
- 4.1M units
- affected scope
- Not Yet Classified
- classification
- May 29, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall number with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action was formally reported on May 29, 2024, with the manufacturer initiating the action on April 5, 2024. It is classified under Critical severity (Not Yet Classified), with a current status of Ongoing. Jiangsu Shenli Medical Production Co., Ltd. is listed as the recalling firm, operating out of Changzhou. Federal records list the affected scope as 4092250, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). Distribution data in the federal record shows the product reached: U.S.: CA, FL, GA, IL, TN, and VA After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship th…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Not Yet Classified) |
| Status | Ongoing |
| Recall number | Not assigned |
| Date reported | May 29, 2024 |
| Date initiated | April 5, 2024 |
| Recalling firm | Jiangsu Shenli Medical Production Co., Ltd. |
| Firm location | Changzhou |
| Affected scope | 4092250 |
| Distribution | U.S.: CA, FL, GA, IL, TN, and VA After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to differen… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026