National Safety Recalls - Sept. 16

Medtronic Bravo esophageal-monitoring devices — 184 serious injuries

FDA on September 15 classified the recall of certain Medtronic/Given Imaging Bravo CF esophageal pH-monitoring capsule delivery devices as Class I, the agency’s most serious category. The capsule can fail to attach properly to the esophagus or fail to detach from the delivery device, potentially causing aspiration, airway obstruction, esophageal perforation or laceration, hemorrhage and retained foreign bodies. Medtronic has reported 184 serious injuries and no deaths. (U.S. Food and Drug Administration)

Affected products are Bravo CF capsule delivery devices FGS-0635 and FGS-0636, with affected lots generally carrying expiration dates through October 20, 2027. Hospitals and other users are being told not to use affected units and to quarantine and return them for replacement. This expands on an FDA early alert issued August 27; the Class I designation is the new development. (U.S. Food and Drug Administration)

FDA Bravo CF recall notice

🚩 “Natural enhancement” products contain hidden Viagra/Cialis ingredients

FDA posted two nationwide recalls on September 15 involving products sold as supplements but found in laboratory testing to contain undeclared sildenafil and tadalafil, the active ingredients in Viagra and Cialis.

X10 Natural Enhancement Supplement was sold through Amazon, Walmart.com and naturefuel.us from December 2024 through June 2026. The liquid comes in a red-and-gold package containing seven red lightning-bolt-shaped sachets. Three lots are affected. (U.S. Food and Drug Administration)

A second product, biQ-FEL 500 mL, was sold through the same online outlets. Two lots are recalled. (U.S. Food and Drug Administration)

The chief danger is for people taking nitrates such as nitroglycerin: sildenafil and tadalafil can interact with those drugs and cause dangerously low blood pressure. Because the prescription drugs are not disclosed on the labels, buyers may have no idea they are taking them. FDA says no adverse events had been reported as of September 14. Consumers are advised to stop using the products. (U.S. Food and Drug Administration)

FDA X10 recall
FDA biQ-FEL recall

🚩 So Delicious frozen dessert — stones and hard objects

Danone USA is recalling So Delicious Dairy Free Salted Caramel Cluster Non-Dairy Frozen Dessert pints because the cashew pieces may contain small stones or other hard foreign material. FDA posted the recall September 15 after consumer complaints. (U.S. Food and Drug Administration)

The recall covers UPC 744473476138, SKU 136603, with best-by dates on or before April 3, 2028. The product was distributed to retail stores across the United States. Consumers should not eat affected pints and can obtain a refund or replacement coupon. No other So Delicious flavors or products are included. (U.S. Food and Drug Administration)

FDA So Delicious recall notice

FDA also expands the sprout-outbreak response

FDA reported September 15 that the supplier of the alfalfa seed linked to the current E. coli/Salmonella sprout outbreak has now recalled the implicated seed lot. The seed was supplied to sprout growers and wholesalers in the U.S. and Puerto Rico as well as internationally. FDA says sprouts grown from that seed should already have been recalled and should no longer be for sale. (U.S. Food and Drug Administration)

CPSC, NHTSA and USDA FSIS

CPSC: No new batch has appeared since September 10. Its current recall page still begins with that date and the Ricky Joy candy, fire spray, button-battery toys and other products already covered. (U.S. Consumer Product Safety Commission)

NHTSA: The newest filings I found remain the September 10 actions, primarily very small Forest River recalls — 195 vans with rearview-camera problems and 60 travel trailers with an LP-gas/fire hazard. Nothing new approaches the scale of the F-150 fuel-tank recall covered yesterday. (Recall Bench)

USDA FSIS: I found no new September 15–16 meat, poultry or processed-egg recall or public-health alert.