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

Limited official informationDrugs

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: Vista...

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

AffectedVistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), d...
RiskDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

Arizer Solo III Portable Vaporizers Recalled

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

AffectedThis recall involves the Arizer Solo III Intergalactic (Black), a portable electronic vaporizer powered by an interna...
RiskThe pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or d...
ActionConsumers should stop using the Arizer Solo III portable electronic vaporizers immediately and contact 7111495 Canada...
Recalled Arizer Solo III Intergalactic (Black) portable electronic vaporizer
Actionable recallConsumer Products

BABESIDE Doll and Stroller Children's Toys Recalled

The recalled toys violate the small parts ban because they are intended for children under three and the small pacifier poses a deadly choking hazard to young children. In addition, the eyes on the plush bear can detach, also posing a choking hazard.

AffectedThis recall involves BABESIDE-branded doll and stroller toys. The play toy sets consist of a pink with red stroller,...
RiskThe recalled toys violate the small parts ban because they are intended for children under three and the small pacifi...
ActionConsumers should stop using the recalled toys' plush bear and pacifier immediately, take them away from children and...
Recalled BABESIDE Doll and Stroller Playset
Actionable recallConsumer Products

Bada Boom Fireworks Pyro Diablo "Diablo Rising" Fireworks

The recalled fireworks violate the ban for aerial fireworks devices intended to produce audible effects because they have a pyrotechnic composition that exceeds the federal limit, posing deadly explosion and burn hazards. Overloaded fireworks can result in...

AffectedThis recall involves Pyro Diablo branded "Diablo Rising" 9 Shots fireworks device, model PD-C5001. The packaging disp...
RiskThe recalled fireworks violate the ban for aerial fireworks devices intended to produce audible effects because they...
ActionConsumers should stop using the recalled fireworks devices immediately and contact Bada Boom Fireworks for a full ref...
Recalled Pyro Diablo “Diablo Rising” 9 Shots
Actionable recallConsumer Products

GOPO Toys Pull String Teething Toys

The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and d...

AffectedThis recall involves GOPO TOYS pull string teething toys. The teething toys consist of an off-white disc shape with a...
RiskThe recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longe...
ActionConsumers should stop using the teething toy immediately, take it away from children and contact GOPO Toys to receive...
Recalled GOPO TOYS Pull String Teething Toy
Actionable recallConsumer Products

Joolz Aer2 Car Seat Adapters for Strollers

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.

AffectedThis recall involves the Aer2 Car Seat Adapters for Joolz Aer2 Strollers. The adapters are designed to transfer the c...
RiskThe recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, pos...
ActionConsumers should stop using the Joolz Aer2 Car Seat Adapters immediately, detach them from the stroller and go to htt...
Recalled Aer2 Car Seat Adapter for Joolz Aer2 Strollers
Actionable recallConsumer Products

Joolz Aer2 Car Seat Adapters for Strollers

The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and an inf...

AffectedThis recall involves the "Classic" and "Deluxe" CooCooBaby Baby Loungers. The recalled baby loungers are made of a fo...
RiskThe baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the min...
ActionConsumers should stop using the baby loungers immediately and contact CooCooBaby for a full refund. Consumers should...
Recalled CooCooBaby Deluxe Lounger – golden brown
Actionable recallConsumer Products

SHEIN Distribution Corporation Michley Children's Pajamas

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

AffectedThis recall involves Michley-branded children's pajamas. The recalled one-piece pajamas were sold in green with a din...
RiskThe recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk o...
ActionConsumers should stop using the recalled pajamas immediately and contact SHEIN for a full refund. Consumers will be a...
Recalled SHEIN's Michley Children's Pajama - green
Actionable recallConsumer Products

Spa Drain Covers Recalled

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.

AffectedThis recall involves Arrogantf white spa/hot tub suction covers that are sold for use as Hot Tub Jet Cover, Spa Drain...
RiskThe recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safet...
ActionSpa owners, spa operators and consumers should stop using spa/hot tubs with the recalled pool drain covers immediatel...
Recalled Arrogantf 3-3/4" Suction Cover
Actionable recallConsumer Products

Veseacky Pajama Sets Recalled

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

AffectedThis recall involves Veseacky pajama sets. The pajama sets consist of a long-sleeve, button-up top with a front pocke...
RiskThe pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or d...
ActionConsumers should stop using the recalled pajama sets immediately and contact Veseacky for a full refund. Consumers wi...
Recalled Veseacky pajama set
Limited official informationPatient-Relevant Medical Devices

Allia IGS 3 Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or trouble...

AffectedAllia IGS 3 Pulse angiographic X-ray system; Allia IGS Pulse angiographic X-ray system; plus 3 additional official va...
RiskGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped wit...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Bicarby Dialysate

There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect G...

AffectedBicarby Dialysate; Model number: RFP-400-G;
RiskThere is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, a...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode,...

Reusable electrodes may not meet expected performance levels.

AffectedBoston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC1...
RiskReusable electrodes may not meet expected performance levels.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Sterile anchors my lack sterility assurance.

AffectedBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
RiskSterile anchors my lack sterility assurance.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

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

AffectedBrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840; Brand Name: CGuard¿ Pr...
RiskStent delivery system may encounter complications during deployment which may result in high resistance or inability...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The E...

It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive);...

AffectedBrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produc...
RiskIt was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on th...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton,...

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

AffectedBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6...
RiskPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar...

Presence of Particulate matter: Particulate matter identified as glass.

AffectedDOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufact...
RiskPresence of Particulate matter: Particulate matter identified as glass.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90)

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

AffectedDuloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (5199...
RiskCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
ActionNot available

Missing from associated official evidence: action.