FDA Devices recall · Reported March 18, 2015
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packa…
Medela Inc. Ef Division recalled - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feed… - a moderate-severity action.
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feed… was recalled by Medela Inc. Ef Division in March 18, 2015. Reason: The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected …. Check the official notice for the remedy. Verify recall #Z-1262-2015 with the FDA Devices before acting.
The recall
Medela Inc. Ef Division issued this moderate-severity FDA Devices recall-The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected ….
- Moderate
- severity level
- 2.0M units
- affected scope
- Class II
- classification
- March 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1262-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1262-2015) was formally reported on March 18, 2015, with the manufacturer initiating the action on February 13, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medela Inc. Ef Division is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 1,959,187, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging. Distribution data in the federal record shows the product reached: Nationwide Distribution.. 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
Reason for recall
The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1262-2015 |
| Date reported | March 18, 2015 |
| Date initiated | February 13, 2015 |
| Recalling firm | Medela Inc. Ef Division |
| Firm location | Brea, CA |
| Affected scope | 1,959,187 |
| Distribution | Nationwide Distribution. |
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-1262-2015) 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? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026