CADD Medication Cassette Reservoir recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3). While medication leakage from a drug delivery device could cause serious consequences, no actual harm has been documented in the source.
Plain-English summary
The CADD Medication Cassette Reservoir, 100mL (Product Code 21-7300-24) manufactured by Smiths Medical ASD Inc. has been recalled. A production equipment malfunction caused weakened weld joints between the medication bag and tubing in certain units, which could result in medication leakage.
The recall affects 26,160 units distributed worldwide. The affected lot numbers are 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, and 4048899. The UDI/DI is 10610586027192.
This is a Class II recall. Patients and healthcare providers should verify whether they have devices from the affected lot numbers.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Device
- Affected units
- 26,160
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 (17)
- UDI/DI 10610586027192
- Lot Numbers: 3971732
- 3971731
- 4034016
- 3977457
- 4013365
- 4019421
- 4019422
- 4034015
- 4037744
- 4037745
- 4034018
- 4034017
- 4046844
- 4046843
- 4053912
- 4048899
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · medication leakage
See all →- HighICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
FDA (Devices) · 2026-09-23
- SevereHillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighMedication cassette reservoirs recalled over weakened bag welds causing leakage
FDA (Devices) · 2025-09-10
- HighFlow stop cassette reservoirs recalled because medication bag welds may weaken
FDA (Devices) · 2025-09-10
Similar recalls
- HighMedication cassette reservoirs recalled over weakened bag welds causing leakage
FDA (Devices) · 2025-09-10
- HighSmiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk
FDA (Devices) · 2015-03-25
- HighCADD 50 mL cassette reservoirs recalled over weakened bag welds
FDA (Devices) · 2025-09-10
- HighCADD 100 mL flow stop reservoirs recalled over weakened bag welds
FDA (Devices) · 2025-09-10
- HighFlow stop cassette reservoirs recalled because medication bag welds may weaken
FDA (Devices) · 2025-09-10
- HighCADD yellow 100 mL reservoirs recalled over weakened medication bag welds
FDA (Devices) · 2025-09-10