Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk
Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a packaging defect (booklet puncturing the lid) which poses a risk to sterility but does not involve a direct structural defect or reported injuries, fitting the Moderate criteria for low-risk contamination or packaging issues.
Plain-English summary
Baxter Healthcare Corp. is recalling 288 units of the GEM FlowCOUPLER, 3.5 mm, sterile EO, single-use implantable device. The device is intended for end-to-end anastomosis of veins and arteries in microsurgical and vascular reconstructive procedures. The recall is due to a defect where the instructions for use booklet may puncture the outer Tyvek lid.
The affected units are identified by lot codes SPI5El2-1049760 through SPI5K10-1096019. The devices were distributed nationwide in the United States as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada.
Healthcare providers and consumers should stop using the affected GEM FlowCOUPLER devices and contact Baxter Healthcare Corp. for further instructions on return or replacement.
The recalled product
- Product
- GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 288
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)
- SPI5El2-1049760 thru SPI5K10-1096019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corp. 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 5 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateBaxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch
FDA (Devices) · 2020-04-15
- HighBaxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss
FDA (Devices) · 2014-08-06
- HighBaxter GEM Flow Coupler Monitor Recalled for Firmware Shutdown Issue
FDA (Devices) · 2020-07-08
- HighBaxter Flow Coupler Monitor Recall Due to Battery Recharge Failure
FDA (Devices) · 2021-02-10
- HighBaxter Recalls GEM Coupler Forceps Due to Potential Rust
FDA (Devices) · 2019-01-02
- HighBaxter Recalls Microbore Catheter Extension Sets Due to Potential Leak
FDA (Devices) · 2015-10-28