nhtsa regulated Recalls

114 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/20 Recall 111 Systems Worldwide Over Intermittent Imaging (2026)

Philips Medical Systems Nederland B.V. recalls 111 Allura Xper FD20/20 imaging systems with System Code 722038. The recall covers 31 units in the United States and 80 abroad. The defect may prevent X-ray imaging from starting or cause intermittent imaging when using the wired foot switch. Stop using the device immediately and follow recall instructions from Philips or your healthcare provider.

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

Philips Allura Xper FD10F Recall for 10 Units Worldwide (2026)

Philips Medical Systems Nederland B.V. recalls 10 Allura Xper FD10F imaging systems sold to hospitals worldwide. The devices may fail to start X-ray imaging or start intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and contact Philips for instructions.

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

Synthes Bone Taps Recall 33-Unit Lot Swap Causes Incorrect Threading (2026)

Synthes bone taps recalled nationwide in the United States after a lot swap affected 33 units sold through multiple retailers. The defect is an incorrect thread caused by a lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8. Healthcare providers should stop using these devices immediately and follow recall instructions from Synthes.

Synthes
A full
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Healthcare Diagnostics Atellica CH A1c_E Recall for 21,291 Units (2026)

Siemens Healthcare Diagnostics recalled 21,291 Atellica CH A1c_E units distributed to laboratories nationwide and internationally in 2026. The recall addresses a depressed result bias when A1c_E is processed with RCRP on the same analyzer. Labs using separate analyzers are not impacted. Stop using the affected module immediately and follow manufacturer instructions. Contact Siemens or your lab’s F

Siemens Healthcare Diagnostics
A potential
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Health & Personal Care
HIGH
FDA DRUG

Radnostix Sodium Iodide I-131 Gel Capsule Pack Recalled for 2,699 Units in 2026

Radnostix recalled 2,699 gelatin capsule packs used with its Sodium Iodide I-131 kit, distributed nationwide in the United States and Puerto Rico. The capsules failed to meet tablet/capsule specifications. Healthcare providers and patients should stop using the product and contact Radnostix for guidance.

SODIUM IODIDE I-131
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

Medline Sterile Radiology Procedure Kits Recalled for Sterility Breach (2026)

Medline Industries recalled 420 Sterile Radiology Procedure Kits, Model DYNDH1491B, distributed nationwide in Minnesota after a potential breach in sterile pouch packaging. The defect may compromise product sterility. Stop using the kit immediately and contact Medline or your healthcare provider for instructions.

Medline Industries, LP
There is
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Health & Personal Care
HIGH
FDA DRUG

Kirkman MAXIMUM Zone 1 4% Lidocaine Cream Recall 178 Bottles (2026)

Kirkman recalled 178 bottles of MAXIMUM Zone 1 4% Lidocaine Cream distributed nationwide in the U.S. by Dermal Source. The recall cites stability data that does not support the stated expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.

Kirkman
Stability Data
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls 14,379 Olympus Biopsy Valve Kits in 2026

Medline Industries, LP recalled 14,379 kits nationwide that include Olympus biopsy valves. The recall concerns rubber fragments detaching in the slit of single-use biopsy valves. Stop using these kits immediately and follow manufacturer instructions for return or replacement.

Medline
Kits contain
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Automated Controller Recall 62 Units in 2026

Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.

Abiomed
Potential that
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Health & Personal Care
HIGH
FDA DRUG

Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall (2026)

Harbin Jixianglong Biotech Co. recalled semaglutide for Rx compounding use distributed nationwide to healthcare providers in the United States. The recall cites CGMP deviations and failure to complete process validation and bacterial endotoxin method validation before distribution. Healthcare providers and patients should stop using this product immediately and contact the manufacturer or their CL

Harbin Jixianglong Biotech Co.
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall 2026 — 6 Packaging Sizes

Harbin Jixianglong Biotech Co. recalled Semaglutide for Rx compounding use nationwide in the United States. The recall cites CGMP deviations and failure to complete endotoxin validation before distribution. Healthcare providers and patients should stop using the product immediately and contact the company or a healthcare provider for guidance via email.

Harbin Jixianglong Biotech Co.
CGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)

Olympus Corporation of the Americas recalled 3,354 units of the OER-Pro endoscope reprocessor on February 12, 2026. MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1443/MAJ-1444 Endoscope Suction Valves Recalled in 2026

Olympus Corporation of the Americas recalls 47,383 MAJ-1443 and MAJ-1444 endoscope suction valves distributed nationwide in the United States. The valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the valves immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units

Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical BAT Coverage Recall 1,489 Units Worldwide in 2026

Burlington Medical recalled 1,489 BAT Coverage units worldwide on 2026-02-11 after a design-related issue was identified. The recall targets attenuation material used in the device. The defect could affect the lifespan of the shielding. Healthcare providers and patients should stop using the device and follow manufacturer instructions. The recall is active as of 2026-04-08.

Burlington Medical
Potential for
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Tag Statistics

Total Recalls
114

Related Tags

electrical hazardimmediate actionstop use immediatelyreturn for refundworkplaceelectronicexplosion riskfda regulatedcpsc regulatedreplacement availableinfant productadult product