nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DRUG

Medline 222,800 Alcohol Prep Pads Recalled for Subpotent Drug (2025)

Medline Industries recalled 222,800 alcohol prep pads nationwide on Sept. 29, 2025 due to subpotent potency. The pads are 2-ply, 70% isopropyl alcohol. Stop using immediately and contact Medline or your healthcare provider for guidance.

Medline Industries
Subpotent Drug
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Health & Personal Care
HIGH
FDA DRUG

AFCO Hand Sanitizer 5515 Recalled for Methanol Risk Nationwide (2025)

AFCO's hand sanitizer 5515 is being recalled nationwide through distributors and retailers. The recall cites cGMP deviations that left methanol risk unexcluded. Consumers and healthcare providers should stop using this product immediately and contact Acuity Specialty Products for guidance.

AFCO
cGMP deviations:
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Health & Personal Care
HIGH
FDA DRUG

ENTECAVIR Entecavir 0.5 mg Tablets Recalled Nationwide Over Impurity (2025)

Ent ecavir 0.5 mg tablets, distributed nationwide in the United States by Zydus Pharmaceuticals USA Inc., are recalled, affecting 912 bottles. The recall is due to an out-of-specification organic impurity detected in a batch, Class II. Healthcare providers and patients should stop using the product immediately and contact Zydus Pharmaceuticals USA for guidance.

ENTECAVIR
Failed impurity/degradation
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Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 62 BD MAX System IVD Units Worldwide Over Credential Breach (2025)

BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical Recall Expands for Perifix FX Epidural Tray and Catheter Over Lid Position Defect (Z

B Braun Medical recalled an epidural anesthesia tray nationwide after finding a lid misalignment in the catheter connector could occur. The recall involves the PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX FX Springwound Catheter with a 17 Ga Tuohy needle and 19 Ga closed-tip catheter. The recall date is 2025-09-18 with report of ongoing action as of 2025-10-15. Healthcare providers,,

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical Recall: 60-Unit Anesthesia Tray Recalled for Catheter Connector Lid Position Issue

B BRAUN MEDICAL INC recalls 60 units of SESK Combined Spinal and Epidural Tray nationwide. The recall targets products distributed to all 50 states. The defective lid on the catheter connector may be in the incorrect position, posing a high-risk device issue. Stop using immediately and follow company instructions for recall remedies.

B BRAUN MEDICAL
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

HeartSine Pad-Pak Defibrillator Pads Recalled for 1,291,165 Units in 2025

HeartSine Technologies recalled 1,291,165 Pad-Pak defibrillator pads sold nationwide in the United States and worldwide. A defect may allow damage pins to disrupt the mechanical fit and electrical contact. Stop using the pads immediately and follow the manufacturer's recall instructions.

HeartSine Technologies
Due to
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid Misalignment in 48,110 Units (2025)

B Braun Medical Inc. recalled 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide to hospitals and surgical centers. The recall cites a potential for the lid of the catheter connector to be in the incorrect position. Hospitals and clinics should stop using the device and contact B Braun Medical for instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid-Position Issue (21,270 Units)

B Braun Medical recalled 21,270 PERIFIX FX Continuous Epidural Anesthesia Tray units distributed nationwide to hospitals and surgical centers after a lid-position defect was identified in the catheter connector. The defect allows the catheter connector lid to be in the incorrect position. Healthcare facilities and clinicians should stop using the device immediately and follow the manufacturer’s or

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Oral Probe Recalled for 5,209 Units Misconfigured as Rectal Probes (2025)

Baxter Healthcare recalled 5,209 oral/axillary probes used with Welch Allyn SureTemp Plus thermometers nationwide in the United States, Canada and Colombia. The probes were inadvertently programmed with the rectal configuration, which can yield a lower temperature reading. Healthcare providers and patients should stop using the affected probes immediately and follow Baxter’s recall instructions.

Baxter Healthcare
Affected oral/axillary
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Health & Personal Care
HIGH
FDA DRUG

IntegraDose Oxytocin IV Solution Recall 2025 for Subpotent Drug, 853 Bags Nationwide

IntegraDose Compounding Services recalled 853 IV bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride. The recall is nationwide in the United States. Testing found no oxytocin in the IV bags. Stop using the product and contact IntegraDose or a healthcare provider for guidance.

IntegraDose Compounding Services
Subpotent Drug:
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Optima NX Recall for Detector Fall Risk (1 Unit)

GE HealthCare recalled 1 Optima NX dual-head gamma camera worldwide after detecting potential detector mounting failure if the unit is moved without proper support. The risk could cause a detector fall and life-threatening injury. Hospitals should stop using the device and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging for guidance.

GE Medical Systems Israel Functional Imaging
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls 37 Maxicam Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare Israel recalled 37 Maxicam dual-head gamma cameras distributed worldwide to hospitals. The recall cites potential detector mounting stress if the devices are moved without adequate support. This could result in a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the device and follow recall instructions from GE HealthCare.

GE HealthCare
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT System Recalled for 4 Units (2025)

UIH Technologies LLC is recalling 4 Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT systems sold in the United States. A third-party outer cover can become trapped between the patient table and gantry during table movement. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions.

Shanghai United Imaging Healthcare
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

Argon Medical Devices Recalls 1,821 Option Elite IVC Filters for Dilator Resistance Risk (2025)

Argon Medical Devices recalled 1,821 Option Elite Vena Cava Filter System devices sold to U.S. hospitals and international distributors. The recall cites a dilator resistance issue within the introducer sheath that could slow procedures and injure venous tissue. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.

Argon Medical Devices
Due to
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    nhtsa regulated Recalls | RecallRadar