FDA Enforcement · Jul 22, 2026
Drug recall: Nystatin Cream USP, (100,000 USP Nystatin Units)
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. — Padagis US LLC · Class II · Ongoing · 180,936 tubes
Recalls & Safety · page 6
Recalls and safety alerts from the FDA, newest first.
FDA Enforcement · Jul 22, 2026
Drug recall: meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 993 units
FDA Enforcement · Jul 22, 2026
Drug recall: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL)
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 106,301 units
FDA Enforcement · Jul 22, 2026
Drug recall: TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL)
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 16,156 units
FDA Enforcement · Jul 22, 2026
Drug recall: AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL)
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 5,762 units
FDA Enforcement · Jul 22, 2026
Drug recall: GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL)
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 20, 160 units
FDA Enforcement · Jul 22, 2026
Drug recall: Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL)
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 31,094 units
FDA Enforcement · Jul 22, 2026
Device recall: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external…
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 — Orthofix U.S. LLC · Class II · Ongoing · 48 units
FDA Enforcement · Jul 22, 2026
Device recall: Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from th… — Boston Scientific Corporation · Class II · Ongoing · 153,921 (US); 119,274 (OUS)
FDA Enforcement · Jul 22, 2026
Device recall: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25…
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 87,277 units
FDA Enforcement · Jul 22, 2026
Device recall: Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break. — Papablic Inc · Class II · Ongoing · 13,400 packs
FDA Enforcement · Jul 22, 2026
Device recall: Papablic Replacement Brush Heads. Model Number: Papablic18B
Potential for brush heads to break. — Papablic Inc · Class II · Ongoing · 14,700 packs
FDA Enforcement · Jul 22, 2026
Device recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer,…
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 1,540 units
FDA Enforcement · Jul 22, 2026
Device recall: ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403;…
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. — ICU Medical, Inc. · Class II · Ongoing · 12525 units
FDA Enforcement · Jul 22, 2026
Device recall: Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). — Daavlin Distributing Company · Class II · Ongoing · 212 units
FDA Enforcement · Jul 22, 2026
Device recall: Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and col… — GE Medical Systems, LLC · Class II · Ongoing · 4 units
FDA Enforcement · Jul 22, 2026
Device recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr…
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 846 units
FDA Enforcement · Jul 22, 2026
Device recall: Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. — Olympus Corporation of the Americas · Class II · Ongoing · 3,241 units
FDA Enforcement · Jul 22, 2026
Device recall: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion…
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 score lines in the hub region. — Oscor Inc. · Class I · Ongoing · 355 units
FDA Enforcement · Jul 22, 2026
Device recall: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). — Daavlin Distributing Company · Class II · Ongoing · 2 units
FDA Enforcement · Jul 22, 2026
Device recall: Optima XR220amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and col… — GE Medical Systems, LLC · Class II · Ongoing · 38 units
FDA Enforcement · Jul 22, 2026
Device recall: General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 1800
FDA Enforcement · Jul 22, 2026
Device recall: ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in…
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diag… — Tosoh Bioscience Inc · Class II · Ongoing · 310 units
FDA Enforcement · Jul 22, 2026
Device recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. — Olympus Corporation of the Americas · Class II · Ongoing · 190 units