CADD Medication Cassette Reservoir Recalled for Weld Defect Risk
Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.
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: This is an FDA Class II recall of a critical medication infusion device where a production defect could result in medication leakage. Although no injuries or hospitalizations have been reported, the potential for malfunction of a life-critical drug delivery device represents a risk-of-harm scenario warranting a High severity rating.
Plain-English summary
Smiths Medical ASD Inc. is recalling 385,558 units of the CADD Medication Cassette Reservoir (100mL, Product Code 21-7302-24) due to a manufacturing defect identified during production.
The cassettes are used in infusion pump systems to deliver medication to patients. A production equipment malfunction may have caused weakened weld joints between the medication bag and tubing. This defect could result in medication leakage during patient use.
The recalled cassettes were distributed worldwide. Specific lot numbers are identified in the FDA recall notice (Z-0011-2025). Patients and healthcare providers should immediately discontinue use of cassettes from the affected lots and contact Smiths Medical for replacement units.
More information is available through the FDA recall notice or by contacting the manufacturer directly.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- medication-leakage
- weld-defect
- device-malfunction
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)
- UDI/DI 10610586027239
- Lot Numbers: 3971709
- 3983317
- 3983316
- 3983315
- 3983318
- 3983327
- 3983320
- 3983321
- 3983323
- 3983328
- 3983322
- 4013357
- 3983325
- 3983324
- 3983329
- 3983326
- 3983330
- 3983332
- 3983331
Distribution
Distribution scope not specified by the agency.
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