FDA daily for Friday, July 17, 2026
In this issue: 11 approvals, 30 device recalls and 68 label changes. 4 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
Oscor Inc. · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sc…
- Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
Oscor Inc. · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sc…
- Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation · Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manif…
- MDP PEPTIDE 9 BIO SUN PRO
HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE · SKINIDEA CO., LTD · TOPICAL
Drug and biologic approvals
FDA date:On Fri, Jul 10 FDA approved 3 new applications (1 brand or biologic, 2 generic) and 8 supplements to existing ones.
- ZYOGREEN
PROVEPHARM SAS · INDOCYANINE GREEN
- RILPIVIRINE HYDROCHLORIDE
LAURUS · RILPIVIRINE HYDROCHLORIDE
- ILOPROST
REGCON HOLDINGS · ILOPROST
Device recalls
FDA date:FDA posted 30 device recalls from 7 firms on Fri, Jul 10.
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
Oscor Inc. · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sc…
- Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
Oscor Inc. · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sc…
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
Oscor Inc. · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sc…
- Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation · Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manif…
- ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introduc…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Prod…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Prod…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
- ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump an…
Abiomed, Inc. · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing…
Label updates
FDA date:68 drug labels took effect on Fri, Jul 3; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- MDP PEPTIDE 9 BIO SUN PRO
HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE · SKINIDEA CO., LTD · TOPICAL
- TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE · REMEDYREPACK INC. · ORAL
- Ibuprofen
IBUPROFEN · REMEDYREPACK INC. · ORAL
- Fluoxetine
FLUOXETINE HYDROCHLORIDE · REMEDYREPACK INC. · ORAL
- Lisinopril
LISINOPRIL · REMEDYREPACK INC. · ORAL
- Glyburide and Metformin Hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE · Rising Pharma Holdings, Inc. · ORAL
- Clonazepam
CLONAZEPAM · REMEDYREPACK INC. · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
Subscribe with any feed reader, or point an email tool at the RSS feed to send each issue as a newsletter. Search any drug, device or company across every FDA dataset in the FDA data explorer.
