FDA Device Recalls

Class IICompleted

Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

Obalon Therapeutics Inc

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

May 23, 2019 · DeviceView details →

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.

AggreGuide A-100 Instrument

Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664

Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508

Monoject Standard Hypodermic Needle Item code: 8881200029

Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045

Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322

Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389

Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522

Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456

Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498

Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314

Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363

Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548

Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078

Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654

Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355