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All consumer recall records

Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.

Actionable recallConsumer Products

Diamond Wipes International CVS Health Medicated Hemorrhoidal Wipes

The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the...

AffectedThis recall involves CVS Health Medicated Hemorrhoidal Wipes. The pain-relieving wipes were sold in boxes of 20 indiv...
RiskThe recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison...
ActionConsumers should secure the wipes out of sight and reach of children immediately and contact CVS for a full refund. C...
Recalled CVS Health Medicated Hemorrhoidal Wipes
Actionable recallConsumer Products

Junpower CR2032 Lithium Coin Batteries Recalled

The lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal ch...

AffectedThis recall involves Junpower CR2032 Batteries (20 pieces) in specific packaging (Packaging model 2023-V3). The produ...
RiskThe lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required u...
ActionConsumers should stop using the recalled coin batteries immediately, place them in an area that children cannot acces...
Recalled Junpower CR2032 batteries (Packaging model 2023-V3)
Actionable recallConsumer Products

Projecting LED Finger Light Toys Recalled

The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuri...

AffectedThis recall involves POPOOO Jungle Safari LED Finger Lights. They were sold in sets of 24 multi-colored lights with w...
RiskThe recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batter...
ActionConsumers should stop using the recalled finger lights immediately, take them away from children and contact POPOOO f...
Recalled POPOOO LED Jungle Safari Projecting Finger Lights
Actionable recallConsumer Products

Rowenta Cordless Vacuum Cleaners

The recalled lithium-ion battery in the vacuum cleaner can overheat and ignite, posing a risk of serious injury from fire and burn hazards.

AffectedThis recall involves cordless vacuum cleaners with a recalled lithium-ion battery that is housed in the handle of the...
RiskThe recalled lithium-ion battery in the vacuum cleaner can overheat and ignite, posing a risk of serious injury from...
ActionConsumers should stop using the vacuum immediately and remove the recalled lithium-ion battery from the handle. Visit...
X-Force Flex vacuum cleaner (red, black and silver) that has the recalled lithium-ion battery in the handle
Actionable recallConsumer Products

Target Gigglescape™ Under the Sea Popping Toy

The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing a choking hazard.

AffectedThis recall involves Gigglescape Under the Sea Popping Toys. The recalled toys have a clear plastic dome attached to...
RiskThe clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessibl...
ActionConsumers should stop using the recalled toy immediately and return it to any Target store for a full refund or conta...
Recalled Gigglescape Under the Sea Popping Toy – Side View
Actionable recallConsumer Products

Topyond Pool Drain Ports with Covers Recalled

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

AffectedThis recall involves Topyond white pool drain port with cover, sold as a Port Replacement Drainer for swimming pools....
RiskThe recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool an...
ActionPool owners, pool operators and consumers should stop using pools with the recalled pool drain port and cover immedia...
Recalled Topyond Pool Drain Port (Top View)
Actionable recallConsumer Products

Vevor Baby Loungers

The recalled baby loungers violate the mandatory safety standard for?infant sleep products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment...

AffectedThis recall involves VEVOR baby loungers. The recalled baby loungers are made of a foam sleeping pad and padded bumpe...
RiskThe recalled baby loungers violate the mandatory safety standard for?infant sleep products. The sides are too low to...
ActionConsumers should stop using the recalled baby loungers immediately and contact Vevor for a full refund. Consumers wil...
Recalled VEVOR Baby Lounger – Snow Deer
Actionable recallConsumer Products

Winco Fireworks International Roman Candles 8 Shot Fireworks

The recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury from explosion and burn hazards.

AffectedThis recall involves the Roman Candles 8 Shot firework devices, Model Number RCLR-W8012. The recalled products were s...
RiskThe recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury...
ActionConsumers should stop using the recalled fireworks immediately and return the fireworks to the store where they were...
Recalled Roman Candles 8 Shot 3-Pack Firework Devices
Actionable recallConsumer Products

Winco Fireworks International Unity 7 Shot 200 Gram Aerial Cake Fireworks

The recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards.

AffectedThis recall involves the Unity 7 Shot 200 Gram Aerial Cake firework devices, model MEF6096. The recalled products wer...
RiskThe recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards.
ActionConsumers should stop using the recalled fireworks immediately and return the fireworks to the store where they were...
Recalled Unity 7 Shot 200 Gram Aerial Cake Firework Devices
Limited official informationFood

1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.

Potential presence of Salmonella.

Affected1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.; 2.0 oz Dirty Sour Cream and Onion Potato Chips,...
RiskPotential presence of Salmonella.
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

6/11oz No Salt Sunflower Seeds

The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.

Affected6/11oz No Salt Sunflower Seeds; 25# Sunflower Seeds C/S; plus 4 additional official variants listed below.
RiskThe firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1...

Potential for thrombus formation during prolonged use of the introducer.

AffectedAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Produ...
RiskPotential for thrombus formation during prolonged use of the introducer.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

AffectedAcumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm N...
RiskDue to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner...

Non-Sterility: Due to presence of Aspergillus penicillioides.

AffectedBD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 A...
RiskNon-Sterility: Due to presence of Aspergillus penicillioides.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile S...

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

AffectedBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Ap...
RiskLack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, S...

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

AffectedBD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicato...
RiskNon-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar...

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Affectedboichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolk...
RiskIngredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Numb...

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for dest...

AffectedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pac...
RiskCertain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-1...

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

AffectedBrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog N...
RiskFirm received a complaint with no clinical impact in which a posterior augment was found within the distal augment pa...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ8161...

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

AffectedConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VA...
RiskFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not init...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs ou...

AffectedDa Vinci ASSY, PSS, SP1098, Part Number: 380601
RiskOperative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structur...
ActionNot available

Missing from associated official evidence: action, consumer scope.