FDA daily for Thursday, October 22, 2026
In this issue: 18 approvals, 32 device recalls, 15 device decisions and 3 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.
- LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics, Inc. · In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expirati…
- Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Num…
Cook Incorporated · The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufa…
Drug and biologic approvals
FDA date:On Thu, Oct 15 FDA approved 5 new applications (1 brand or biologic, 4 generic) and 13 supplements to existing ones.
- SODIUM PHOSPHATES
AMNEAL · SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- BUPRENORPHINE HYDROCHLORIDE
GLAND · BUPRENORPHINE HYDROCHLORIDE
- EVOXAC
COSETTE PHARMS NC · CEVIMELINE HYDROCHLORIDE
- MELOXICAM
NOVITIUM PHARMA · MELOXICAM
- CIPROFLOXACIN AND DEXAMETHASONE
ALEMBIC · CIPROFLOXACIN, DEXAMETHASONE
Device recalls
FDA date:FDA posted 32 device recalls from 10 firms on Thu, Oct 15.
- LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics, Inc. · In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expirati…
- Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Num…
Cook Incorporated · The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufa…
- MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated…
Microgenics Corporation · Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH)…
- DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Beckman Coulter, Inc. · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, th…
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200…
Beckman Coulter, Inc. · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, th…
- TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Howmedica Osteonics Corp. · Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the…
- TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Howmedica Osteonics Corp. · Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the…
- Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics Corp. · Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the…
- TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Howmedica Osteonics Corp. · Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the…
- Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Medline Industries, LP · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leak…
- 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ…
Medline Industries, LP · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leak…
- Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product…
Medline Industries, LP · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leak…
Device clearances and approvals
FDA date:FDA decided 7 510(k)s and 8 PMA decisions on Thu, Oct 8.
- One Coat Bond; One Coat Bond SL
Dent4You AG · Dental
- Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology
- CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)
Wuhan Phomed Technology Co., Ltd. · General, Plastic Surgery
- MeCare Alpha (MCA2019)
IVT Medical, Ltd. · General, Plastic Surgery
- NEXT-Cue
Neuroxt, Inc. · Neurology
Label updates
FDA date:3 drug labels took effect on Thu, Oct 8.
Browse label updates in FDA data →FDA did not answer for Drug shortages, 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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