CME America Recalls BodyGuard Microset Infusion Administration Sets
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-161XPS). The recall involves 345,244 units distributed across the United States and in Canada and the UK.
The recall was issued because the infusion administration sets may have a delivery inaccuracy ranging from minus 42.8% to plus 17.5%. This inaccuracy could cause over-infusion or under-infusion of therapy when used with an infusion pump system.
Healthcare facilities and consumers who have these products should stop using them and contact CME America for instructions on how to return or dispose of the devices.
The recalled product
- Product
- BodyGuard Microset, REF: A120-161XPS
- Manufacturer
- CME America, LLC
- Affected units
- 345,244
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 (1)
- All lots within expiry date
Distribution
Part of a larger recall action
This product is one of 37 recalled by CME America, LLC 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 37 products in this recall →Related recalls
Same manufacturer · CME America, LLC
See all →- SevereCME America Recalls NeoThrive Syringe Pumps Due to Motor Wear
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
FDA (Devices) · 2020-12-09
- HighCME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
FDA (Devices) · 2020-12-09
- SevereCME America T-Syringe Pump Recall for Motor Wear and Fluid Damage
FDA (Devices) · 2020-12-09
Same hazard · over infusion
See all →- HighSIGMA Spectrum infusion pumps recalled over defective grease on the gears
FDA (Devices) · 2026-01-28
- CriticalInfusion pump modules recalled because drops can damage the bezel assembly
FDA (Devices) · 2025-11-26
- HighInfusion pumps recalled because degrading grease may cause excessive therapy delivery
FDA (Devices) · 2025-09-03
- HighInfusion Pump Manual Instructs Users to Leave Safety Clamp Open
FDA (Devices) · 2025-03-05
- HighIvenix Infusion System Software Defect May Delay or Cause Incorrect Infusions
FDA (Devices) · 2024-03-20