États-Unis Recalls

Toyota Motor Engineering & Manufacturing - Loss of Drive Power

An unexpected loss of drive power increases the risk of a crash.

Piaggio Group Americas, Inc. - Headlight May Fail

Loss of lighting can reduce visibility, increasing the risk of a crash.

Clover Hill Dairy Expands Recall to Include All Clover Hill Dairy Brand Cheese Due to Possible Health Risk

Spa Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Arrogantf

The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to consumers.

Veseacky Pajama Sets Recalled Due to Risk of Serious Injury Death from Burn Hazard; Violate Mandatory Standards for Children's Sleepwear

The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.

SHEIN Distribution Corporation Recalls Michley Children's Pajamas Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standard for Children's Sleepwear

The recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.

Joolz Recalls Aer2 Car Seat Adapters for Strollers Due to Risk of Serious Injury from Fall Hazard

The recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, posing a risk of serious injury from a fall hazard.

Power Plate Meals, LLC Recalls Frozen Meatloaf Products Due to Misbranding and Undeclared Allergens

Unreported Allergens

Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada

The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Halyard, Drape Pack. Kit Code: LMDP36-01.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.

Microbial contamination of sterile products

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

The cannulation of the CCS screw is not centered.

Halyard, Eye Bag Pack. Kit Code: UIEB48-01.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.