Medical DeviceMay 29, 2024
GMAX SYR 30ML/LL syringe recall — FDA Z-2114-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
May 2024 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceMay 29, 2024
Philips Achieva 1.5T Initial system Model Number (REF): 781178 recall — FDA Z-1838-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L BLUE LIDO recall — FDA Z-2077-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems recall — FDA Z-1853-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
MEDLINE SYR 3ML L/L recall — FDA Z-2049-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
GMAX SYR 6ML/LL syringe recall — FDA Z-2110-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical recall — FDA Z-1864-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/S WHITE LIDO recall — FDA Z-2092-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L YELLOW LIDO recall — FDA Z-2082-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L recall — FDA Z-2052-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L RED recall — FDA Z-2067-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 60ML L/L recall — FDA Z-2045-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Tornier S.A.S Stryker Blueprint Software, Catalog #BPUE001 recall — FDA Z-1883-2024
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do…
Class IIFDA: OngoingTornier S.A.S.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L BLUE recall — FDA Z-2064-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDIGRATIVE 100cc/ml disposable luer lock syringe recall — FDA Z-2100-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 1ML TB recall — FDA Z-2053-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/S recall — FDA Z-2051-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L YELLOW LIDO recall — FDA Z-2088-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/S RED recall — FDA Z-2093-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems recall — FDA Z-1859-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
Cadwell Industries Cascade IOMAX Cortical Module, REF: 190296-200 recall — FDA Z-1882-2024
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential…
Class IIFDA: OngoingCadwell Industries Inc.
Medical DeviceMay 29, 2024
MEDLINE SYR 30ML L/L recall — FDA Z-2043-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips Respironics BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and recall — FDA Z-1813-2024
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory…
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceMay 29, 2024
MEDLINE SYR 5ML L/L RED recall — FDA Z-2057-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.