FDA daily for Tuesday, September 22, 2026
In this issue: 5 shortage updates, 15 approvals, 13 device recalls and 17 device decisions. 3 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.
- TRETINOIN
ZYDUS LIFESCIENCES · TRETINOIN
- TESTOSTERONE
TWI PHARMS · TESTOSTERONE
Drug shortages
FDA date:FDA updated 5 shortage entries on Mon, Sep 21: 1 new, 1 to be discontinued, 3 status updates.
- Arsenic Trioxide Injection
Fresenius Kabi USA, LLC
- Methylprednisolone Acetate Injection
Pfizer Inc. · Limited Availability · Reason: Demand increase for the drug
- Dexmedetomidine Hydrochloride Injection
Pfizer Inc. · Available
- Clindamycin Phosphate Injection
Pfizer Inc. · Available
- Penicillin G Benzathine Injection
Pfizer Inc. · Limited Availability · Reason: Other
Drug and biologic approvals
FDA date:On Tue, Sep 15 FDA approved 5 new applications (1 brand or biologic, 4 generic) and 10 supplements to existing ones.
- TRETINOIN
ZYDUS LIFESCIENCES · TRETINOIN
- MILNACIPRAN HYDROCHLORIDE
STRIDES PHARMA · MILNACIPRAN HYDROCHLORIDE
- MILNACIPRAN HYDROCHLORIDE
MACLEODS PHARMS · MILNACIPRAN HYDROCHLORIDE
- GARZULYS
EMERGE BIOSCIENCE PTE. LTD. · INSULIN ASPART-FSAN
- EPINEPHRINE
DIFGEN PHARMS · EPINEPHRINE
- TESTOSTERONE
TWI PHARMS · TESTOSTERONE
Device recalls
FDA date:FDA posted 13 device recalls from 7 firms on Tue, Sep 15.
- BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 Sma…
BD SWITZERLAND SARL · Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
- NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD · Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
WELL LEAD MEDICAL CO. LTD · The 6Fr suction catheter could not pass through the samples smoothly.
- GM Helix Implant, REF: 109.984;
Straumann USA LLC · There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
PTW FREIBURG · When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may…
- Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Happiest Baby, Inc · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Device clearances and approvals
FDA date:FDA decided 14 510(k)s and 3 PMA decisions on Tue, Sep 8.
- EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
DRTECH Corporation · Radiology
- Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
Zhejiang Geyi Medical Instrument Co., Ltd. · Obstetrics/Gynecology
- da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc. · Gastroenterology, Urology
- MODI System
DreaMed Diabetes, Ltd. · Clinical Chemistry
- N22 Offset Humeral Head
Shoulder Innovations, Inc. · Orthopedic
- Emboliner Embolic Protection System (EPC-03)
Emboline, Inc. · Cardiovascular
- LANDMARK Total Knee System
Smith & Nephew, Inc. · Orthopedic
- Reusable SmartPeg
Osstell AB · Dental
- Power Wheelchair (OS-R-M01I)
Beijing OrionStar Technology Co., Ltd. · Physical Medicine
- b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
B-One Ortho, Corp. · Orthopedic
- Dental Barriers and Sleeves (AB0006)
ANI Co., Ltd. · General, Plastic Surgery
- Electric wheelchair (HC819N, HC830N, HC831N)
Yongkang Hengyi Vehicle Co., Ltd. · Physical Medicine
- LiteSet Trays
Nobel Biocare AB · General Hospital
FDA did not answer for Labels, Drug recalls, Food and supplement recalls while this issue was written; those sections will fill in on a later visit.
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.
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