CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report

GMAX SYR/LL syringe recalled by Jiangsu Shenli Medical

Jiangsu Shenli Medical Production is recalling GMAX SYR/LL, 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

Lot, batch or date codesLot Code: LOT: SL22070103 SL22030103 SL21120111 SL21090103 SL21030103
Quantity recalled60,000

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-2124-2024
FDA event ID
94520
Recalling firm
Jiangsu Shenli Medical Production, 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
E-Mail
Reason category
Other Reasons

Timeline

5 Apr 2024Recall initiated by company
29 May 2024Published in enforcement report+54 days
10 Jun 2024Classified 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).

Product as listed by the FDA

Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M 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

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: SL22070103 SL22030103 SL21120111 SL21090103 SL21030103

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

86 other products · FDA event 94520
ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Syr L/l Green recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Purple recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Cntrl L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Green recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue Saline recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l White recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LS syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR Control syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow Hep/saline recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL Blue syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Cntr L/l Yellow recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr/l White Contrast recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr/l Purple recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red Heparin recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr/l White Hep Flush recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Cntrl L/l Green recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red Cont recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Green Cont recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Cntrl L/l Yellow Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Cntrl L/l Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr Tb recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedigrative 100cc/ml disposable luer lock syringe recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s White Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Purple recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LS syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Green recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l White recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LS syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LS syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red Nitro recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical (cc) Luer Lock Sterile Latex Free Non Pyrogenic recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/s recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow Nitro recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Purple recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr/l Blue Contrast recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr/ls recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue Heparin recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Control recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIWolf Medical - Wolf-pak Disposable Syringe recalledJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue Saline recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Blue recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l White recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Green recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL Blue syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red Lido recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Yellow Cont recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l White Saline recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
CLASS IIMedline Syr L/l Purple Nitro recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide

More recalls from Jiangsu Shenli Medical Production

All 87
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Syr L/l Purple Nitro recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
DeviceCLASS IIMedline Syr L/l Red recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
DeviceCLASS IIGMAX SYR/LL syringe recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
DeviceCLASS IIMedline Syr L/l recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide
DeviceCLASS IIMedline Syr L/l White Saline recalled by Jiangsu Shenli MedicalJiangsu Shenli Medical ProductionOtherNationwide

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