All Recalls

Unapproved food additive.

Fairfield Gourmet Food Corp. d/b/a David s Cookies ,28 Industrial Road, Fairfield NJ 07004has initiated a recall of Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g) plastic package (i.e.) Clamp shell 8 package per case, LOT # BS23212 (Manufactured on July, 31, 2023) because of MISLABELED / UNDECLARED ALLERGENS (Peanuts)

No pre-market notification and Mixing instructions not in ounces

Undeclared Allergen: Soy

Undeclared allergen (egg)

Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.

Software update

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Potential PCBA leaching from tubing of hemodialysis machines.

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

Potential PCBA leaching from tubing of hemodialysis machines.

Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.

Some surgical glove sterile pouches were not completely sealed.

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

There is a potential for blood backfill leakage and foreign material.