CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report
Wolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalled
Jiangsu Shenli Medical Production Co is recalling Wolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic, distributed nationwide in the US. The recall was initiated on 5 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2106-2024
- FDA event ID
- 94520
- Recalling firm
- Jiangsu Shenli Medical Production Co, Changzhou
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Apr 2024
- FDA classified
- 10 Jun 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 5 Apr 2024 | Recall initiated by company | |
| 29 May 2024 | Published in enforcement report | +54 days |
| 10 Jun 2024 | Classified by FDA | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No
Where it was distributed
U.S. Nationwide distribution in the states of 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 different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
Nationwide CaliforniaFloridaGeorgiaIllinoisTennesseeVirginia
Questions about this recall
Is Wolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalled?
Yes. Jiangsu Shenli Medical Production Co recalled Wolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic on 5 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2106-2024.
Why was it recalled?
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Which lots are affected?
Lot Code: LOT: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006
Where was it sold?
U.S. Nationwide distribution in the states of 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 different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Jiangsu Shenli Medical Production Co
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|---|---|---|---|---|---|
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| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |