Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 23, 2015
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Conn
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Moog Medical Devices Group recalled Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connecto… - a moderate-severity action.
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connecto… was recalled by Moog Medical Devices Group in December 23, 2015. Reason: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to …. Check the official notice for the remedy. Verify recall #Z-0415-2016 with the FDA Devices before acting.
The recall
Moog Medical Devices Group issued this moderate-severity FDA Devices recall-Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to ….
- Moderate
- severity level
- Class II
- classification
- December 23, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0415-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0415-2016) was formally reported on December 23, 2015, with the manufacturer initiating the action on November 20, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Moog Medical Devices Group is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 12,014,130 sets.
The documented reason for this recall is: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. Distribution data in the federal record shows the product reached: Distributed to the state of MN.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
12,014,130 sets
Related Recalls
6
3 from same agency
Product description
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
Reason for recall
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0415-2016 |
| Date reported | December 23, 2015 |
| Date initiated | November 20, 2015 |
| Recalling firm | Moog Medical Devices Group |
| Firm location | Salt Lake City, UT |
| Affected scope | 12,014,130 sets |
| Distribution | Distributed to the state of MN. |
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-0415-2016) 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? ▼
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.. Recalled by Moog Medical Devices Group. Units affected: 12,014,130 sets.
Why was this product recalled? ▼
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0415-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed to the state of MN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0415-2016) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 23, 2015. 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 July 2026.