🔍 RecallPedia

All Recalls

95,102 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,655
Consumer Products

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).

Apotex

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Sep 5, 2025 Prescription Drugs Nationwide View Details →

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Aug 28, 2025 Other Medical Devices Nationwide View Details →

Biograph mMR. Model Number: 10433372.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Aug 28, 2025 Other Medical Devices Nationwide View Details →

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

North American Rescue

🏥 Medical Devices Class I - Dangerous

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

Jul 1, 2025 Other Medical Devices Nationwide View Details →

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific

🏥 Medical Devices Class I - Dangerous

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Aug 29, 2025 Surgical Instruments Nationwide View Details →

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific

🏥 Medical Devices Class I - Dangerous

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Aug 29, 2025 Surgical Instruments Nationwide View Details →

ZAP-X Radiosurgery System, Model: 300150

Zap Surgical Systems

🏥 Medical Devices Class I - Dangerous

If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.

Jul 25, 2025 Other Medical Devices Nationwide View Details →

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Draeger

🏥 Medical Devices Class I - Dangerous

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Sep 9, 2025 Diagnostic Equipment Nationwide View Details →

Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH

Medline Industries

🏥 Medical Devices Class I - Dangerous

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

Jul 31, 2025 Surgical Instruments Nationwide View Details →