FDA Enforcement · Jul 1, 2026
Drug recall: Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10)
Subpotent Drug — The Harvard Drug Group LLC · Class II · Ongoing · 790 Cartons
Latest medical news · page 122
The latest headlines across every section, pulled from official and open-access sources.
FDA Enforcement · Jul 1, 2026
Drug recall: PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of Sterility — PReye LLC · Class II · Ongoing · approximate 50 to 60 bottles
FDA Enforcement · Jul 1, 2026
Drug recall: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL…
Non-Sterility: Due to presence of Aspergillus penicillioides. — CareFusion 213, LLC · Class I · Ongoing · 193,440 applicators
FDA Enforcement · Jul 1, 2026
Drug recall: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)
Presence of foreign substance — ANI Pharmaceuticals, Inc. · Class III · Ongoing · 6564 bottles
FDA Enforcement · Jul 1, 2026
Drug recall: Perampanel CIII Tablets, 6mg
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing · 3,456 30-count bottles
FDA Enforcement · Jul 1, 2026
Drug recall: Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles
CGMP Deviations — Amgen, Inc. · Class II · Ongoing · N/A
FDA Enforcement · Jul 1, 2026
Drug recall: Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles
CGMP Deviations — Amgen, Inc. · Class II · Ongoing · 9565 bottles
FDA Enforcement · Jul 1, 2026
Drug recall: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. — CareFusion 213, LLC · Class I · Ongoing · 178,000 applicators
FDA Enforcement · Jul 1, 2026
Device recall: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple,…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
FDA Enforcement · Jul 1, 2026
Device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail…
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infec… — Dexcom, Inc. · Class II · Ongoing · N/A
FDA Enforcement · Jul 1, 2026
Device recall: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines &…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 112 units
FDA Enforcement · Jul 1, 2026
Device recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number:…
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 435 units
FDA Enforcement · Jul 1, 2026
Device recall: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. — Ventec Life Systems, Inc. · Class II · Ongoing · 1
FDA Enforcement · Jul 1, 2026
Device recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY…
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
FDA Enforcement · Jul 1, 2026
Device recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C…
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
FDA Enforcement · Jul 1, 2026
Device recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer…
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 168 units
FDA Enforcement · Jul 1, 2026
Device recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 0
FDA Enforcement · Jul 1, 2026
Device recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF…
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
FDA Enforcement · Jul 1, 2026
Device recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. — Philips North America Llc · Class II · Ongoing · 285 units
FDA Enforcement · Jul 1, 2026
Device recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
FDA Enforcement · Jul 1, 2026
Device recall: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
FDA Enforcement · Jul 1, 2026
Device recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 288 units
FDA Enforcement · Jul 1, 2026
Device recall: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 13 units
FDA Enforcement · Jul 1, 2026
Device recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435.…
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 17 units