Maine recalls

The steam diffuser in these portable saunas can be positioned too close to your body, allowing hot steam to contact your skin. Giantex has received nine reports of burns, including one second-degree burn.

SkinnyDipped Dark Chocolate Coconut Almond Bites in certain lots may contain undeclared peanut or peanut butter, even though peanuts are not an intended ingredient. The issue was discovered after a consumer found peanut butter–containing products in the wrapper. People with peanut allergies could have a serious allergic reaction.

A rubber hose inside the X-ray tube cooling unit (type CU3101) on certain Philips Integris-Allura systems can degrade and leak oil over time. This reduces cooling performance and causes the system to automatically switch to low-dose mode with a "Tube cooler problem" message that cannot be cleared by restarting. The affected cooling units were manufactured between February 2016 and May 2020.

A cooling hose in certain Philips Allura X-ray systems manufactured between February 2016 and May 2020 may degrade over time and leak oil. If oil leakage reduces cooling performance below a safe threshold, the system automatically switches to low-dose fluoroscopy and cannot be fixed by restarting.

A cooling hose in certain Philips Azurion X-ray systems may degrade over time and leak oil, reducing cooling performance. When oil levels drop too far, the system automatically switches to low-dose mode and cannot be fixed by restarting.

C.R. Bard has recalled certain Silastic Brand Foley Catheters (5cc and 30cc models) due to staining on the catheter surface. The affected catheters were distributed across the U.S. and Canada.

Certain Philips Azurion fluoroscopy systems may experience mechanical wear in the Float Tabletop control, which could impair the longitudinal and transverse (side-to-side and front-to-back) movement of the examination table. This wear could affect the system's ability to position patients correctly during imaging procedures.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94965), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier that protects the device before use. This affects 260 units distributed worldwide, including in the United States.

Certain lots of the Medtronic DLP Retrograde Cannula (Model 94915), a catheter used during heart bypass surgery, may have a breach in their sterile packaging. This could allow contamination before the device is used. No injuries have been reported.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913L), a catheter used in heart surgery, may have a compromised sterile barrier. This could allow contamination during the surgical procedure. The issue affects 481 units distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913), a catheter used in heart-lung bypass surgery, may have a compromised sterile barrier. This could allow contamination before use. The affected product was distributed worldwide, including the United States.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94725), a catheter used in heart surgery, may have a breach in their sterile packaging. This could potentially expose the device to contamination before use. The affected lots have been identified by lot number and GTIN code.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94665) used in heart-lung bypass surgery may have a compromised sterile barrier. This could allow contamination of the device before use. The affected lots have been identified and distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94215T), a catheter used during heart surgery, may have a compromised sterile barrier. This affects 600 units distributed worldwide. No injuries have been reported.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94115T), a catheter used during heart-lung bypass surgery, may have a breach in their sterile packaging. This could allow contamination of the device before use. The affected lots have been identified and are listed in the recall notice.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier. This could allow contamination of the sterile product before use during heart surgery.

The straight inserter tool on certain OneLIF Interbody Cage implants may fail to attach properly to the cage. This could prevent secure engagement during spinal fusion surgery, potentially causing procedural delays or requiring surgeons to choose a different implant.

ICU Medical oncology infusion kits with extension sets may develop leaks during chemotherapy administration. If a leak occurs during therapy, patients may receive less medication than intended, and healthcare workers or patients could be exposed to hazardous drugs.

Tangent Endoscopy's Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) can develop fractures at the tip of the shaft during use. While the fractured pieces have not completely detached in reported cases, a broken catheter tip could affect device function or potentially cause patient harm.

Certain Swan-Ganz Pacing Catheters (Model D200F7) may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, medication loss, or blood loss during use.

Certain Swan-Ganz Jr Catheter models may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, loss of medication, or blood loss during use.

Certain Swan-Ganz catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This defect can result in loss of medication, blood loss, or infection during use.

Ghirardelli Perfectly Premium Frappe Mix Classic White in 50 oz, 10 lb, and 30 lb sizes may be contaminated with Salmonella. The contamination was discovered during testing. No illnesses have been reported so far.

Ghirardelli Premium Hot Cocoa Mix (32 oz / 2 lb containers) may be contaminated with Salmonella. The affected product was distributed across the U.S., Canada, and several other countries. No illnesses have been reported to date.

Ghirardelli Sweet Ground Powder Chocolate (48 oz packages) may be contaminated with Salmonella. The affected product was distributed across the U.S. and several countries. Two lot codes are involved: S293260 (best by 12/31/2027) and S293261 (best by 1/31/2028).

Ghirardelli Sweet Ground Powder White Chocolate Flavored (50 oz bags) may be contaminated with Salmonella. The affected product was distributed across the U.S. and internationally. Three specific lot codes with a best-if-used-by date of 7/31/2027 are involved.

Ghirardelli Perfectly Premium Frappe Mix Vanilla (48 oz) may be contaminated with Salmonella. The contamination was discovered during testing. About 2,934 units across three lot codes were affected and distributed to multiple U.S. states and several countries.

Ghirardelli Perfectly Premium Frappe Mix Chocolate Flavored (50 oz bags) may be contaminated with Salmonella. The affected product was distributed across the U.S. and internationally. No illnesses have been reported.

Ghirardelli Perfectly Premium Frappe Mix Chocolate Flavored (sold in 10-lb and 30-lb containers) may be contaminated with Salmonella. The contamination was detected during testing. Affected products were distributed across the U.S. and internationally.

Ghirardelli Chocolate Company is recalling Perfectly Premium Frappe Mix White Mocha (50 oz bags) due to potential Salmonella contamination in the nonfat dry milk ingredient. The affected product was distributed across the U.S. and internationally.