FDA daily for Friday, August 21, 2026
In this issue: 2 shortage updates, 26 device recalls and 157 label changes. 2 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.
- BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit f…
Bard Access Systems, Inc. · After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary…
Drug shortages
FDA date:FDA updated 2 shortage entries on Thu, Aug 20: 2 status updates.
- Lisdexamfetamine Dimesylate Capsule
SpecGx LLC · Available
Device recalls
FDA date:FDA posted 26 device recalls from 17 firms on Fri, Aug 14.
- BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit f…
Bard Access Systems, Inc. · After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary…
- Lago X
Spectral Instruments Inc · Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
- Ami HTX
Spectral Instruments Inc · Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 1088452180809…
Covidien, LLC · Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Foundation Medicine, Inc. · Software issue that can cause an increase in spontaneous software closures.
- One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Intersurgical Inc · Devices could potentially be occluded or partially occluded.
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Intersurgical Inc · Devices could potentially be occluded or partially occluded.
- Dentsply Sirona Capsule Mixer Model No. 5546068
SDI Limited · Potential for electrical discharge from unit when unplugged.
- Cardiac Workstation 5000. Product Number: 860439.
Philips North America Llc · Device will intermittently provide inaccurate data related to native heart rate.
- Cardiac Workstation 7000. Product Number: 860441.
Philips North America Llc · Device will intermittently provide inaccurate data related to native heart rate.
- Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVI…
Kico Knee Innovation Company · Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
- Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-35…
Arrowhead DE LLC · Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamm…
Label updates
FDA date:157 drug labels took effect on Fri, Aug 7; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- ABRILADA
ADALIMUMAB-AFZB · A-S Medication Solutions
- tofacitinib
TOFACITINIB · Zydus Pharmaceuticals USA Inc. · ORAL
- Ramipril
RAMIPRIL · Bryant Ranch Prepack · ORAL
- Sacubitril and Valsartan
SACUBITRIL AND VALSARTAN · Umedica Laboratories USA Inc. · ORAL
FDA did not answer for Drug recalls, Clearances, Approvals 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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