CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Medline procedure kits labeled as follows: Echostim Block Set recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as follows: Echostim Block Set, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCodes: 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, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896

Quantity recalled3396 units

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-0511-2025
FDA event ID: 95615
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2024
FDA classified: 22 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

16 Oct 2024	Recall initiated by company
22 Nov 2024	Classified by FDA	+37 days
4 Dec 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A

Where it was distributed

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Nationwide

Questions about this recall

Is Medline procedure kits labeled as follows: Echostim Block Set recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure kits labeled as follows: Echostim Block Set on 16 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0511-2025.

Why was it recalled?

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Which lots are affected?

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, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896

Where was it sold?

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

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.

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