suffocation risk Recalls

495 recalls tagged with “suffocation risk”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT160 Bronchoscope Recall Due to High Hazard Risk — 262 Units Affected

Olympus recalled 262 units of the BF-XT160 bronchoscope after concerns regarding its safe use with laser and high-frequency therapy equipment. Additional instructions for use (IFU) updates clarify potential hazards. Healthcare providers and patients must cease use immediately and follow the manufacturer's recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H190 Bronchovideoscope Recall Expanded for IFU Updates in 2025

Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TH1100 Bronchoscope Recall Expanded for IFU Clarifications (2025)—High Risk

Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-PE2 Bronchoscope Recall Expands with 4,289 Units Aboard Outside US

Olympus Corporation of the Americas confirms a Class I recall of the BRONCHOFIBERSCOPE BF TYPE PE2. The recall covers 2 units in the US and 4,289 units outside the US. Updated IFU guidance aims to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TQ170 Bronchoscope Recall Expanded for IFU Clarifications

Olympus Corporation of the Americas recalls the BRONCHOVIDEOSCOPE BF-1TQ170. The recall is active with 2,092 units in the outside US market and no US units affected. The action seeks updated instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers should stop use and follow manufacturer recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1T60 Bronchofiberscope Recall for IFU Updates (2025)

Olympus recalled 3,216 BF-1T60 bronchofiberscopes distributed nationwide and internationally after updating instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. The recall updates guidance to reduce risk during advanced energy-device procedures. Clinicians and facilities should stop using the devices and follow manufacturer instructions for recall.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

BioPro Recalls 147 Metal and Ceramic Femoral Heads Over Sterility Packaging Issue

BioPro recalled 147 femoral head components distributed in the US. The devices cover metal cobalt chromium and ceramic heads in sizes 22, 28, 32, 36 and 40 millimeters. The recall cites a packaging defect that could compromise the sterile barrier. If implanted, the loss of sterility could pose infection risk. Hospitals and surgeons should follow BioPro recall instructions immediately.

BioPro
Potential packaging
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Health & Personal Care
HIGH
FDA DEVICE

Iantrek C-Rex UNO CRX-120 Goniotomy Instrument Recalled for Packaging Integrity Issue (2025)

Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments, CRX-120 models, distributed nationwide to healthcare facilities. The recall cites potential compromised integrity of the sterile packaging. Healthcare providers and patients should stop using the device immediately and follow recall instructions via the manufacturer.

Iantrek
Potential for
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Recalled URMYWO Baby Lounger – Grey Feather
HIGH
CPSC

URMYWO Baby Loungers Recalled for Suffocation and Fall Hazards; 2025 Recall Active

URMYWO recalled its baby loungers on 2025-09-04 after reports of suffocation and fall hazards. The recall targets URMYWO loungers style grey feather sold via Amazon by Pomona. The devices fail to meet infant sleep standards due to short side walls and excessive pad thickness. Consumers should stop using the loungers and request a full refund.

URMYWO
The baby
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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 Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.

American Contract Systems
Identified products
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