Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 18, 2016
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-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 and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the F
Instructions for use booklet may puncture the outer Tyvek lid.
Baxter Healthcare Corp. recalled GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Pr… — a moderate-severity action.
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Pr… was recalled by Baxter Healthcare Corp. in May 18, 2016. Reason: Instructions for use booklet may puncture the outer Tyvek lid.. Check the official notice for the remedy. Verify recall #Z-1631-2016 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Devices recall — Instructions for use booklet may puncture the outer Tyvek lid..
- Moderate
- severity level
- 118 units
- affected scope
- Class II
- classification
- May 18, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1631-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1631-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on April 21, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 118 units.
The documented reason for this recall is: Instructions for use booklet may puncture the outer Tyvek lid. Distribution data in the federal record shows the product reached: Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
118 units
Related Recalls
6
6 from same agency
Product description
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-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 and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Reason for recall
Instructions for use booklet may puncture the outer Tyvek lid.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1631-2016 |
| Date reported | May 18, 2016 |
| Date initiated | April 21, 2016 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Deerfield, IL |
| Affected scope | 118 units |
| Distribution | Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1631-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-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 and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.. Recalled by Baxter Healthcare Corp.. Units affected: 118 units.
Why was this product recalled? ▼
Instructions for use booklet may puncture the outer Tyvek lid.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1631-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1631-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 18, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.