Device recall: Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Class II FDA enforcement event 98907. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II, in the words of FDA
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
Avanos Medical, Inc. started this device recall on 30 Apr 2026. The firm address in the FDA record is in Alpharetta, GA. FDA put the recall in Class II. FDA event 98907 has 20 product records. The first FDA enforcement report date is 17 Jun 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution.
Recalling firm
Avanos Medical, Inc., Alpharetta, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
20 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2333-2026 | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | 231 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2334-2026 | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 | 61 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2335-2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | 31 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2336-2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | 41 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2337-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-4320 | 49 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2338-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320 | 72 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2339-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6312 | 43 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2340-2026 | Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No | 54 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2341-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit | 22 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2342-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No | 901 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2343-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No | 132 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2344-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14 | 208 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2345-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20 | 3,184 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2346-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24 | 1,006 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2347-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No | 53 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2348-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20 | 1,615 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2349-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24 | 234 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2350-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14 | 218 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2351-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20 | 6,005 kits | Class II | Ongoing | 17 Jun 2026 |
| Z-2352-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24 | 1,205 kits | Class II | Ongoing | 17 Jun 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 20Median of the firm: 1
- Events of the firm on the register
- 19
Other events of the firm
Official channels
- FDA enforcement report Z-2333-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98907. https://recallregister.com/fda/ii/98907/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution.
- What quantity of product is in FDA event 98907?
- The event has 20 product records. The first record gives this quantity:
231 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.