MEDLINE ultrasound procedure kit connectors recalled due to insertion malfunction
Medline Industries is recalling procedure kits with connectors that may fail to open fully, preventing proper catheter insertion. The recall affects 3,396 units distributed in the U.S. and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a functional defect that could impede proper medical procedure performance. No hospitalizations, injuries, or deaths have been reported, classifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling approximately 3,396 MEDLINE procedure kits used for ultrasound-guided regional anesthesia procedures. The recalled kits include the ECHOSTIM BLOCK SET (Reference DYNJRA9043S) and ULTRASOUND BLOCK PREP TRAY (Reference PAIN1622A).
The connectors in these kits may not allow catheters to be inserted as intended if the connector is not in the fully open position. This defect could prevent healthcare providers from performing ultrasound-guided block procedures correctly.
The affected products were distributed nationwide in the United States, as well as to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Specific lot numbers have been identified in the FDA recall notice.
Facilities and healthcare practitioners with affected kits should stop use immediately and contact Medline Industries for instructions regarding returns or replacement units.
The recalled product
- Product
- MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- connector-malfunction
- procedure-impediment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Codes: 1) DYNJRA9043S
- UDI/DI 10193489888287(each) 40193489888288(case)
- Lot Numbers: 23CBE390
- 23CBO216
- 23EBM309
- 23EBP979
- 23EBS281
- 23GBV099
- 23HBG915
- 23IBG610
- 23IBG611
- 23JBQ712
- 23KBC341
- 2) PAIN1622A
- UDI/DI 10193489891690 (each) 40193489891691 (case)
- Lot Numbers: 21ELA821
- 21GLA615
- 21KLA308
- 22ALA608
- 22CLA681
Distribution
Distributed nationwide across the United States.
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