nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Cardiac Cath Lab Kits Due to Re-Gassed Sterilization Risk (

American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.

American Contract Systems
Identified products
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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 DEVICE

American Contract Systems Recalling 32,433 UDPG88W PICC G-TUBE Pack in 2025 Recall

American Contract Systems recalled 32,433 UDPG88W PICC G-TUBE PACK medical kits nationwide after a nonconformance in Ethylene Oxide sterilization led to re-gassing. The devices have not been validated for multiple sterilization cycles. Healthcare providers and patients should stop using the kit immediately and follow recall instructions.

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

Zydus Chlorpromazine Hydrochloride 200 mg Recall Expands Nationwide Over CGMP Deviations

The FDA confirms a nationwide recall of Zydus Lifesciences Chlorpromazine Hydrochloride tablets 200 mg (NDC 70710-1133-1) distributed by Zydus Pharmaceuticals USA. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable intake. Consumers and healthcare providers should stop using the product immediately and contact the distributor for guidance.

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

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 50 mg 100-count Recall 2025

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles distributed nationwide in the United States. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product immediately and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc for guidance.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets Recall 100-Count Bottles (2025)

Zydus Lifesciences Ltd. recalled chlorpromazine hydrochloride tablets nationwide in the United States after tests found N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The issue involves CGMP deviations in manufacturing at the India facility and distribution by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. Healthcare providers and patients should stop using the product, 0

Zydus Lifesciences
CGMP Deviations:
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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 DRUG

Sun Pharmaceutical Radiopharmaceutical Kit Recall: 1,870 Kits Recalled for OOS Dissolution Issue

Sun Pharmaceutical Industries recalled 1,870 kits nationwide after an out-of-specification dissolution test for sulphate in Sodium Tartrate Dihydrate used to produce Mertiatide. The recall affects Rx-only kits distributed across the U.S. Healthcare providers and patients should stop using the product immediately and follow guidance from Sun Pharmaceutical. Contact information is provided by the UQ

Sun Pharmaceutical Industries
Failed Dissolution
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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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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/10 Recall 45 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalls 45 Allura Xper FD20/10 imaging systems worldwide due to internal component deterioration. The CMOS battery, hard disk drive and/or power supply may fail. Motorized movements can become unavailable while imaging remains possible. Stop using the device and follow manufacturer instructions.

Philips Medical Systems Nederland B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland B.V. Recalled 98 Imaging Systems for CMOS Battery, HDD, PSU Deteri

Philips Medical Systems Nederland B.V. recalls 98 imaging systems worldwide after reports of component deterioration. Systems may lose motorized movements due to CMOS battery, hard disk drive, or power supply deterioration. Imaging remains available. Stop using the device and follow manufacturer instructions.

Philips Medical Systems Nederland B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20 Biplane Recall Affects 268 Units Worldwide (2025)

Philips Medical Systems Nederland B.V. recalled 268 Allura Xper FD20 Biplane imaging systems worldwide, including 102 in the United States. The recall cites deterioration of internal components that could disable motorized movements. Hospitals should stop using the devices immediately and follow the manufacturer’s recall instructions.

Philips Medical Systems
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Philips Medical Systems Netherlands B.V. Allura Xper FD20/20 OR Table Recall Affects 3 Units

Philips Medical Systems Netherlands B.V. recalled 3 Allura Xper FD20/20 OR Tables worldwide, including the US, on 2025-09-03 after detection of degradation in internal components. The recall cites CMOS battery, hard disk drive, and/or power supply unit deterioration. Motorized movements may fail while imaging remains available. The recall is active. Stop using the device following recall guidance.

Philips Medical Systems Netherlands B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Faces High-Risk Recall for Allura Xper FD20/15 BIOS Battery

Philips Medical Systems Nederland B.V. recalls 300 units of the Allura Xper FD20/15 with model 722058 after the BIOS battery may deplete prematurely, causing startup failure. The recall covers worldwide distribution. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Inpeco Recall: 8 FlexLab FLX Potassium Test System Units Over Unverified HIL Function (2025)

Inpeco recalled eight FlexLab FLX System Potassium Test System units sold in California and New York. The recall targets the Sample Integrity Module HIL function, which detects hemolysis, icterus and lipemia. The FDA has not evaluated this function for safety or effectiveness, risking erroneous results or delays. Labs should stop using the device immediately.

Inpeco
The FlexLab
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Recall Expands for Allura Xper FD20/15 OR Table Model 722059 (2025

Philips Medical Systems Nederland B.V. recalls 8 medical tables worldwide due to BIOS battery depletion risk. The recall affects Allura Xper FD20/15 OR Tables with model number 722059. The BIOS battery may deplete faster than expected, causing the system not to start without warning. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Sulfamethoxazole and Trimethoprim 800 mg/160 mg 100-Tablets Recall 2025

Major Pharmaceuticals recalls sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets sold nationwide. A specific lot of packaging coil used in production was found to contain a microorganism in the packaging area, though no microorganism was detected on the tablets. Consumers should stop using the product and follow guidance from Major Pharmaceuticals or their healthcare provider.

Sulfamethoxazole and Trimethoprim
Presence of
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Tag Statistics

Total Recalls
370

Related Tags

chemical hazardimmediate actionstop use immediatelyreturn for refundreplacement availablefda regulatedpoisoning riskadult productpet relatedbattery poweredfederal law violationcpsc regulated