Device recall: Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes…
Class II FDA enforcement event 94520. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Jiangsu Shenli Medical Production Co., Ltd. started this device recall on 5 Apr 2024. The firm address in the FDA record is in Changzhou. FDA put the recall in Class II. FDA event 94520 has 88 product records. The first FDA enforcement report date is 29 May 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Jiangsu Shenli Medical Production Co., Ltd., Changzhou, China.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
88 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 4092250 | Not yet classified | Ongoing | 29 May 2024 | |
| Z-2042-2024 | Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No | 502250 | Class II | Ongoing | 29 May 2024 |
| Z-2043-2024 | 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 | 4092250 | Class II | Ongoing | 29 May 2024 |
| Z-2044-2024 | Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No | 139100 | Class II | Ongoing | 29 May 2024 |
| Z-2045-2024 | Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No | 1117800 | Class II | Ongoing | 29 May 2024 |
| Z-2046-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No | 2097200 | Class II | Ongoing | 29 May 2024 |
| Z-2047-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No | 38852100 | Class II | Ongoing | 29 May 2024 |
| Z-2048-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No | 494000 | Class II | Ongoing | 29 May 2024 |
| Z-2049-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No | 11584000 | Class II | Ongoing | 29 May 2024 |
| Z-2050-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No | 754600 | Class II | Ongoing | 29 May 2024 |
| Z-2051-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No | 619200 | Class II | Ongoing | 29 May 2024 |
| Z-2052-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No | 13574000 | Class II | Ongoing | 29 May 2024 |
| Z-2053-2024 | Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No | 1700000 | Class II | Ongoing | 29 May 2024 |
| Z-2054-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No | Class II | Ongoing | 29 May 2024 | |
| Z-2055-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles for single use Component: No | 20000 | Class II | Ongoing | 29 May 2024 |
| Z-2056-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No | 12000 | Class II | Ongoing | 29 May 2024 |
| Z-2057-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No | 95200 | Class II | Ongoing | 29 May 2024 |
| Z-2058-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No | 25200 | Class II | Ongoing | 29 May 2024 |
| Z-2059-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No | 44800 | Class II | Ongoing | 29 May 2024 |
| Z-2060-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No | 22400 | Class II | Ongoing | 29 May 2024 |
| Z-2061-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for single use Component: No | 35000 | Class II | Ongoing | 29 May 2024 |
| Z-2062-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No | 525,700 syringes | Class II | Ongoing | 29 May 2024 |
| Z-2063-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No | 325500 | Class II | Ongoing | 29 May 2024 |
| Z-2064-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No | 820400 | Class II | Ongoing | 29 May 2024 |
| Z-2065-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No | 346500 | Class II | Ongoing | 29 May 2024 |
| Z-2066-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for single use Component: No | 749400 | Class II | Ongoing | 29 May 2024 |
| Z-2067-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No | 39200 | Class II | Ongoing | 29 May 2024 |
| Z-2068-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No | 133600 | Class II | Ongoing | 29 May 2024 |
| Z-2069-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No | 230800 | Class II | Ongoing | 29 May 2024 |
| Z-2070-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No | 124800 | Class II | Ongoing | 29 May 2024 |
| Z-2071-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No | 178400 | Class II | Ongoing | 29 May 2024 |
| Z-2072-2024 | Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No | 0 | Class II | Ongoing | 29 May 2024 |
| Z-2073-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No | 0 | Class II | Ongoing | 29 May 2024 |
| Z-2074-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No | 18900 | Class II | Ongoing | 29 May 2024 |
| Z-2075-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No | 40800 | Class II | Ongoing | 29 May 2024 |
| Z-2076-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No | 25200 | Class II | Ongoing | 29 May 2024 |
| Z-2077-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No | 42000 | Class II | Ongoing | 29 May 2024 |
| Z-2078-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single use Component: No | 7000 | Class II | Ongoing | 29 May 2024 |
| Z-2079-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No | 39200 | Class II | Ongoing | 29 May 2024 |
| Z-2080-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without needles for single use Component: No | 7000 | Class II | Ongoing | 29 May 2024 |
| Z-2081-2024 | 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 | 9800 | Class II | Ongoing | 29 May 2024 |
| Z-2082-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No | 23800 | Class II | Ongoing | 29 May 2024 |
| Z-2083-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON-Sterile syringes without needles for single use Component: No | 12600 | Class II | Ongoing | 29 May 2024 |
| Z-2084-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No | 33600 | Class II | Ongoing | 29 May 2024 |
| Z-2085-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No | 7000 | Class II | Ongoing | 29 May 2024 |
| Z-2086-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No | 50400 | Class II | Ongoing | 29 May 2024 |
| Z-2087-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without needles for single use Component: No | 0 | Class II | Ongoing | 29 May 2024 |
| Z-2088-2024 | Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No | 4800 | Class II | Ongoing | 29 May 2024 |
| Z-2089-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No | 9800 | Class II | Ongoing | 29 May 2024 |
| Z-2090-2024 | Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No | 2800 | Class II | Ongoing | 29 May 2024 |
| Z-2091-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No | 30800 | Class II | Ongoing | 29 May 2024 |
| Z-2092-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No | 700 | Class II | Ongoing | 29 May 2024 |
| Z-2093-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No | 0 | Class II | Ongoing | 29 May 2024 |
| Z-2094-2024 | Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No | 17280 | Class II | Ongoing | 29 May 2024 |
| Z-2095-2024 | Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No | 3840 | Class II | Ongoing | 29 May 2024 |
| Z-2096-2024 | Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No | 12160 | Class II | Ongoing | 29 May 2024 |
| Z-2097-2024 | Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No | 0 | Class II | Ongoing | 29 May 2024 |
| Z-2098-2024 | Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No | 44800 | Class II | Ongoing | 29 May 2024 |
| Z-2099-2024 | Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No | 9050240 | Class II | Ongoing | 29 May 2024 |
| Z-2100-2024 | Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No | 110000 | Class II | Ongoing | 29 May 2024 |
The table shows 60 of 88 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 88
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 94520. https://recallregister.com/fda/ii/94520/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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…
- What quantity of product is in FDA event 94520?
- The event has 88 product records. The first record gives this quantity:
4092250
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.