federal law violation Recalls

305 recalls tagged with “federal law violation”.

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

Cardinal Health 200 Salem Sump Gastroduodenal Tubes Recalled Worldwide for ARV Breakage

Cardinal Health 200, LLC recalled Salem Sump gastroduodenal tubes worldwide after reports of anti-reflux valve breakage. The ARV can fail under excessive force during use. Healthcare providers and patients should stop using the device immediately and follow the manufacturer instructions for recall communication.

Cardinal Health 200
Firm has
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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-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

B Braun Medical ESPOCAN Spinal/Epidural Tray Recalled Over Lid Position Risk

B Braun Medical recalled 10,130 ESPOCAN spinal/epidural trays nationwide after discovering potential for the catheter connector lid to be in an incorrect position. The recall covers multiple product codes and UDI numbers. Healthcare providers must stop using affected units and follow manufacturer instructions for remediation.

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

Enterix InSure ONE FIT Recall Affects 201,426 Tests Over False Negatives (2025)

Enterix recalled 201,426 InSure ONE Fecal Immunochemical Test kits after a sensitivity failure linked to Test Card Lot TT241102. The issue may cause false negative results. Healthcare providers and patients should stop using the affected kits and follow the manufacturer’s recall instructions.

Enterix
InSure ONE
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Recalled Bottle of Bariatric Fusion High ADEK Multivitamin
HIGH
CPSC

Blueroot Health Recalls Bariatric Fusion Iron Multivitamins Over Child Poisoning Risk (2025)

Blueroot Health recalled Bariatric Fusion iron multivitamin bottles after discovering the packaging is not child-resistant. The recall involves two bottle types with 45 mg of iron. Affected bottles lack the required push-down-and-turn caps and carry specific lot numbers. Consumers should stop using the product and contact Blueroot Health for a free child-resistant replacement cap.

Blueroot Health
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Medline Excelsior Medical 0.9% Saline Flush Syringes Recalled Over Concentration Deviation (8.27M)

Medline Recall: Excelsior Medical 0.9% Sodium Chloride Injection, USP, 10 mL fill prefilled saline flush syringes EMZ111240 is being recalled. The notice covers 8,267,150 syringes distributed across the United States and Canada. The risk is a concentration deviation of sodium chloride. Healthcare facilities should stop using the product and follow recall instructions. See the FDA recall page for完整

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 BD Alaris Infusion Sets Recalled for Flow, Bolus Accuracy Issues (2025)

CareFusion 303 BD Alaris infusion pump modules and compatible infusion sets are recalled nationwide in the U.S. and multiple international markets. The recall covers reference numbers including C24101E and 10015414 and related SmartSite components. The defect may cause flow rate and bolus accuracy deviations, and incorrect occlusion timing. Stop using the device and follow recall instructions from

CareFusion
Infusion pump
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P150 Bronchoscope Recall Expanded Over IFU Clarifications (2025)

Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.

Olympus Corporation of the Americas
Additional IFU
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Biscotti Recalled for Undeclared Red 40

Gina Marie Bakery LLC recalled 172 cases of Toasted Almond & Cherry Biscotti after the FDA flagged undeclared Red 40. The recall is classified as high hazard. Consumers should avoid the product and contact the company for refunds or replacements.

Gina Marie Bakery
Undeclared Red
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Recalled AR-15 Chamber Lock Pro (Red)
HIGH
CPSC

StopBox USA Recalls AR-15 Chamber Lock Pro for Risk of Serious Injury or Death

StopBox USA recalls AR-15 Chamber Lock Pro shipped June 2 to July 15, 2025. The recall covers locks designed to chamber-lock AR-15 style rifles. The defect allows the lock to be forcibly removed, enabling unauthorized access to the firearm. StopBox urges immediate stop-use and provides refunds or replacements.

StopBox USA
A manufacturing
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems LKRA40G Radiology Pack Recalled Over Unvalidated Re-sterilization (HIGH)

American Contract Systems recalled 32,433 radiology packs after a nonconformance during EO gas injection. The items were re-gassed and not validated for multiple sterilization cycles. The recall is active as of 2025-10-22. US distribution included SD, IA, MN, WA, IL. Health risks prompt immediate removal from use.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Chlorpromazine Hydrochloride 25 mg 100-count Tablets Recalled Nationwide (2025)

Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride tablets, 25 mg, 100-count bottles distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc. for

Chlorpromazine Hydrochloride
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20 OR Table Recalled for 174 Units Worldwide in 2025

Philips Medical Systems Nederland recalled 174 Allura Xper FD20 OR Tables worldwide, including 45 in the United States. The devices may deteriorate internally, rendering motorized movements inoperable. Hospitals and clinics should stop using the devices and follow the manufacturer's recall instructions.

Philips Medical Systems Nederland
Systems may
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Tag Statistics

Total Recalls
305

Related Tags

electrical hazardchemical hazardsuffocation riskinfant producttoddler productadult productelderly productcpsc regulatednhtsa regulatedstop use immediatelyreturn for refundreplacement available
    federal law violation Recalls | RecallRadar