🏥 Medical Devices Class I - Dangerous
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
All Recalls
95,094 total recalls in our database
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
🏥 Medical Devices Class I - Dangerous
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Northeast Laboratory Services
🏥 Medical Devices Class I - Dangerous
Product marketed without a 510 (k)
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
MicroAire Surgical Instruments
🏥 Medical Devices Class I - Dangerous
Complaints that the cannula bent/broke during surgery.
🏥 Medical Devices Class I - Dangerous
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
🏥 Medical Devices Class I - Dangerous
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
🏥 Medical Devices Class I - Dangerous
The firm received a complaint of the battery exploding while recharging.
Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Fresenius Medical Care Renal Therapies Group
🏥 Medical Devices Class I - Dangerous
Dialyzer header leak due to possible improper torque
MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
MicroAire Surgical Instruments
🏥 Medical Devices Class I - Dangerous
MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
Focus Diagnostics
🏥 Medical Devices Class I - Dangerous
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.
CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Focus Diagnostics
🏥 Medical Devices Class I - Dangerous
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
Focus Diagnostics
🏥 Medical Devices Class I - Dangerous
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Rollerblade inline skating helmets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The helmet's plastic shell can crack where the straps attach, causing the helmet to shift and move on the wearer's head. This can result in a head injury hazard to the user in the event of a fall.
Yamaha Recreational Off-Highway Vehicles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Water can get into the throttle cable and if it freezes during cold weather, the ice can prevent the throttle from returning to idle. This can cause the rider to lose control, posing crash and injury hazards.
Coleman® CTAC Lithium-Ion Flashlights
Kaper Industrial LTD, of Hong Kong, China
🏠 Consumer Products Class I - Dangerous
The lithium-ion batteries can overheat, posing a fire hazard to consumers.