ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms
ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.
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: The recall involves a medical device with reported functional issues (occlusion alarms) that pose a risk of harm to patients, but the source text does not report specific injuries, hospitalizations, or fatalities, fitting the criteria for a High severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical Inc is recalling 31,050 units of SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02. The recall is being conducted because of reports of distal occlusion alarms occurring during the use of these administration sets.
The affected products are indicated for the delivery of fluids from a container to a patient's epidural space and are intended for use with Sapphire Infusion Systems. The recall covers units distributed in the United States and internationally to Canada. The specific UDI for the recalled product is 108877870074, and all codes are affected.
Healthcare providers and facilities should stop using the affected Sapphire Epidural Sets and contact ICU Medical Inc for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
- Manufacturer
- ICU Medical Inc
- Affected units
- 31,050
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 (2)
- UDI 108877870074
- All codes
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · ICU Medical Inc
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
FDA (Devices) · 2019-10-23
- HighICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
FDA (Devices) · 2019-10-23
- HighICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk
FDA (Devices) · 2019-10-23
- HighICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
FDA (Devices) · 2019-10-23
- HighICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- ModerateICU Medical Recalls Infusion Sets with Incorrect Spin Collars
FDA (Devices) · 2018-04-18