These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

3,609 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGH
FDA DEVICE

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228,...

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential for
Read more
HIGH
FDA DEVICE

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for...

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Erbe Medical
Devices providing
Read more
HIGH
FDA DEVICE

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Erbe Medical
Devices providing
Read more
HIGH
FDA DEVICE

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Erbe Medical
Devices providing
Read more
Food & Beverages
HIGH
FDA FOOD

HEYTEA USA Coconut Drink 1 Recalled Over Undeclared Milk in 12,677 Cartons (2026)

HEYTEA USA INC recalls 12,677 cartons of Coconut Drink 1 sold for catering establishments in multiple states after undeclared milk was found. The product contains milk not listed on the label. Consumers should not consume the product and contact HEYTEA USA INC for refund or replacement by email.

HEYTEA USA
Product contains
Read more
HIGH
FDA DEVICE

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula ...

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Zimmer
Ten complaints
Read more
HIGH
FDA DEVICE

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Boston Scientific
For some
Read more
HIGH
FDA DEVICE

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448,...

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Boston Scientific
For some
Read more
Health & Personal Care
HIGH
FDA DRUG

Biocon Pharma Prazosin Hydrochloride 1mg 100-Count Capsules Recalled for Nitrosamine Impurity (2026)

Biocon Pharma Inc. recalled 88,008 bottles of Prazosin Hydrochloride capsules, 1 mg, 100-count bottles, nationwide in the United States. A cGMP deviation detected N-nitroso-prazosin impurity C above acceptable limits. Consumers and healthcare providers should stop using this product immediately and contact Appco Pharma LLC or a healthcare provider for guidance.

Biocon Pharma
cGMP deviation:
Read more
Health & Personal Care
HIGH
FDA DRUG

Biocon Pharma Prazosin Hydrochloride 5mg Recall 28,157 Bottles Over Nitrosamine Impurity (2026)

Biocon Pharma Inc. recalled 28,157 bottles of PRAZOSIN HYDROCHLORIDE capsules, distributed nationwide in the USA. The recall cites cGMP deviation due to detection of N-nitroso-prazosin impurity C above acceptable limits. Stop using the product immediately and contact Appco Pharma LLC or your healthcare provider for guidance.

Prazosin Hydrochloride
cGMP deviation:
Read more
Health & Personal Care
HIGH
FDA DRUG

Biocon Prazosin Hydrochloride 2 mg Capsules Recalled for Nitrosamine Impurity (58,896 bottles, 2026)

Biocon Pharma Inc. recalled 58,896 bottles of Prazosin Hydrochloride Capsules, USP, 2 mg, 100-count bottle. The product was distributed nationwide in the USA and manufactured by Appco Pharma LLC. A cGMP deviation detected N-nitroso-prazosin impurity C above acceptable limits. Consumers and healthcare providers should stop using this product immediately and contact Appco Pharma LLC or their health‑

Prazosin Hydrochloride
cGMP deviation:
Read more
Previous
12345...181
Next
Advertisement