Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that m…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merit Medical Systems, Inc. recalled Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produ… - a moderate-severity action.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produ… was recalled by Merit Medical Systems, Inc. in August 21, 2024. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. …. Check the official notice for the remedy. Verify recall #Z-2578-2024 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. ….
- Moderate
- severity level
- Class II
- classification
- August 21, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2578-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2578-2024) was formally reported on August 21, 2024, with the manufacturer initiating the action on June 11, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 168157 kits.
The documented reason for this recall is: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC,…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
168157 kits
Related Recalls
6
3 from same agency
Product description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2578-2024 |
| Date reported | August 21, 2024 |
| Date initiated | June 11, 2024 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | South Jordan, UT |
| Affected scope | 168157 kits |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA,… |
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 (Z-2578-2024) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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.
Frequently Asked Questions
What product was recalled? ▼
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures. Recalled by Merit Medical Systems, Inc.. Units affected: 168157 kits.
Why was this product recalled? ▼
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2578-2024.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2578-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.