Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Walgreens Maximum Strength Tinted Acne Treatment Cream is being recalled for benzene contamination. The product was distributed nationwide; affected consumers should stop use immediately.
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or causing unintended extubation.
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
Remel, Inc. is recalling approximately 41 Zebra Thermal Barcode Printer GX430t power supply units due to a potential fire hazard. The power supplies may overheat, creating a fire risk.
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.