Tubes, Gastrointestinal (and Accessories)
Gastroenterology, Urology · 21 CFR 876.5980
Recent MDR events
26,072 adverse event reports on file
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026MalfunctionAvanos Medical Inc.3011270181-2026-00140
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026MalfunctionAvanos Medical Inc.3011270181-2026-00141
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026MalfunctionAvanos Medical Inc.3011270181-2026-00142
- DUODOPA_DUOPAJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00250
- Duopa/DuodopaJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00251
- DUODOPA_DUOPAJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00252
- DUODOPA_DUOPAJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00253
- DUODOPA_DUOPAJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00254
- DUODOPA_DUOPAJul 31, 2026InjuryAbbvie - Medical Device Center3010757606-2026-00255
- CARDINAL HEALTHJul 30, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00248
Event type breakdown
Recalls
268 recall events for this product code
- Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Brand Name: CORFLO
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2333-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Brand Name: CORFLO
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2334-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO* Safety PEG Kit
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2335-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO* Safety PEG Kit
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2336-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2337-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2338-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2339-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: CORFLO Safety PEG Kit with ENFit Connector
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2340-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2341-2026 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedJun 5, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2342-2026 · View FDA record ↗
Registered firms
687 firms currently registered for this product code
Avanos Medical, Inc.
Alpharetta, GA, US
Vygon Portugal
Balter-Paredes Porto, PT
Fortune Medical Instrument Corp.
Taoyuan City, TW
Sei Medical S.a. De C.v.
Juarez Chihuahua, MX
Hollister Incorporated
LIBERTYVILLE, IL, US
Multi-med, Inc.
Keene, NH, US
Isomedix Operations Inc
El Paso, TX, US
Abbvie Inc
North Chicago, IL, US
Lynx Medical Pennsylvania
ERIE, PA, US
Sterigenics U.s., Llc
Ontario, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Ningbo Tianyi Medical Appliance Co., Ltd.
Ningbo Zhejiang, CN
Syncro Medical Innovations, Inc.
Macon, GA, US
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Avent S. De R.l. De C.v.
NOGALES Sonora, MX
Sterigenics Us Llc
Fort Worth, TX, US
Cardinal Health
Hazelwood, MO, US
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Seisa Medical Inc
El Paso, TX, US
510(k) clearances
650 clearances for this product code
- C.R. Bard, Inc.Jul 10, 2026
K253514 · Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
- Changzhou Xin Neng Yuan Medical Stapler Co.,LtdApr 10, 2025
K250389 · XNY Disposable Gastric Calibration Tube
- ConvatecMar 28, 2025
K243228 · Flexi-Seal AIR (with ENFit Connector)
- Amb MedtecJan 17, 2025
K242336 · hygh-tec Drainage II
- Tools For Surgery, LLCJan 10, 2025
K242901 · ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
- Gravitas Medical, Inc.Nov 22, 2024
K241169 · Entarik NI Feeding Tube System
- Avanos Medical, Inc.Oct 25, 2024
K241185 · CORGRIP* SR NG/NI Tube Retention System
- Avanos Medical, Inc.Jun 6, 2024
K240965 · CORTRAK* 2 Enteral Access System (20-0950)