Recall archive

All consumer recall records

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

Limited official informationPatient-Relevant Medical Devices

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

AffectedSurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered);...
RiskPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Software anomaly that causes a false display of error code 5018.

AffectedThuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
RiskSoftware anomaly that causes a false display of error code 5018.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

TMJ Bilateral Implants, REF: CHG020

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

AffectedTMJ Bilateral Implants, REF: CHG020
RiskCustom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag,...

Incorrect product formulation: bag did not contain copper and famotidine per label.

AffectedTotal Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volu...
RiskIncorrect product formulation: bag did not contain copper and famotidine per label.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

VOCSN+Pro package, REF: PRT-00853-000

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of...

AffectedVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
RiskRespiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Actionable recallConsumer Products

Combination Smoke and Carbon Monoxide (CO) Detectors Recalled

The recalled detectors can fail to alert consumers of a fire, posing a risk of serious injury or death from smoke inhalation or burns.

AffectedThis recall involves Treatlife Smoke and Carbon Monoxide (CO) Detectors. The alarms are AA battery operated and have...
RiskThe recalled detectors can fail to alert consumers of a fire, posing a risk of serious injury or death from smoke inh...
ActionConsumers should contact Treatlife Technology to receive a full refund. Consumers should continue using the recalled...
Recalled Treatlife Smoke and Carbon Monoxide (CO) Detector
Actionable recallConsumer Products

Daikin Comfort Technologies Manufacturing Amana Air Conditioners and Heat Pumps

The heating element can remain energized during a ground fault, despite being turned off, posing a risk of fire or burn injury to consumers.

AffectedThis recall involves certain Amana brand Window-Room-Air-Conditioners and Through the Wall air conditioners or heat p...
RiskThe heating element can remain energized during a ground fault, despite being turned off, posing a risk of fire or bu...
ActionConsumers should stop using the recalled products immediately and contact Daikin Comfort Technologies Manufacturing,...
Recalled Amana Through the Wall (TTW) air conditioner and heat pumps (models beginning with PB)
Actionable recallConsumer Products

Honlyne LED Party Favors Recalled

The LED party favors violate the mandatory safety standard for consumer products because the battery compartment within the light-up products contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swal...

AffectedThis recall involves Honlyn LED party favors. The party favors include 20 LED hair fiber optic clips, 16 LED glasses,...
RiskThe LED party favors violate the mandatory safety standard for consumer products because the battery compartment with...
ActionConsumers should stop using the recalled party favors immediately and contact Huizhou Rongheng Network Technology for...
Recalled Honlyne LED Party Favors
Actionable recallConsumer Products

Kith Retail Children's Loungewear Sets

The recalled children's loungewear sets violate the mandatory flammability standards for children's sleepwear, posing a risk of serious burn injuries.

AffectedThis recall involves Kith-branded children's loungewear sets. The recalled woven pajamas consist of a long-sleeved sh...
RiskThe recalled children's loungewear sets violate the mandatory flammability standards for children's sleepwear, posing...
ActionConsumers should stop using the loungewear immediately and contact Kith Retail for a full refund. Consumers will be a...
Recalled Kith Kids Kithmas Plaid Lounge Set
Actionable recallConsumer Products

Montessori Busy Board Toys Recalled

The busy boards violate the mandatory safety standard for toys because magnets can detach, posing a deadly ingestion hazard. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in th...

AffectedThis recall involves Small Fish Montessori Busy Board toys, model 2512JX02. The busy board consists of a wooden base...
RiskThe busy boards violate the mandatory safety standard for toys because magnets can detach, posing a deadly ingestion...
ActionConsumers should stop using the recalled busy boards and immediately take them away from children. Consumers can cont...
Recalled Montessori Busy Board Toy
Actionable recallConsumer Products

Raychy Children's Light Sneakers Recalled

The recalled sneakers violate the mandatory standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard.?Additionally, the packaging and product do not...

AffectedThis recall involves Raychy Children's Light Sneakers Unisex. The sneakers are available in red, black, and blue, eac...
RiskThe recalled sneakers violate the mandatory standard for consumer products with button cell and coin batteries becaus...
ActionConsumers should stop using the sneakers immediately and contact Carina and Rambo for a refund. Consumers will be ask...
Recalled Raychy Children's Light Sneaker in red
Actionable recallConsumer Products

Shield Line MedPride Baby Oil Bottles

The baby oil contains low-viscosity hydrocarbons, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The baby oil's packaging is not child-resistant, posing a risk of serious injury or illness from poisoning if t...

AffectedThis recall involves MedPride Baby Oil bottles. The baby oil comes in a clear bottle with a pink cap and a white and...
RiskThe baby oil contains low-viscosity hydrocarbons, which must be in child-resistant packaging, as required by the Pois...
ActionConsumers should secure the baby oil out of sight and reach of children immediately and contact Shield Line for a ref...
Recalled MedPride Baby Oil - Front
Actionable recallConsumer Products

Southern Telecom Expands of Lomi Waxing Kits

The roll-on warmers' power cord can overheat and short circuit, posing a risk of serious injury or death from fire, burn and electrical shock hazards.

AffectedThis recall involves the Lomi Roll-On Waxing Kit with Wax Cartridge & Wax Strips, model numbers LOMB2003PK and LOMB20...
RiskThe roll-on warmers' power cord can overheat and short circuit, posing a risk of serious injury or death from fire, b...
ActionConsumers should stop using the recalled waxing kits immediately and contact Southern Telecom for a full refund. Cons...
Recalled Lomi Roll-On Waxing Kit (LOMB2004PK)
Actionable recallConsumer Products

Super Off-Road Solar Power Banks Recalled

The solar power bank's lithium-ion battery can swell and overheat, posing a burn hazard to consumers.

AffectedThis recall involves the Super Off-Road 12,000 mAh Solar Wireless Power Bank, a power bank with solar charging capabi...
RiskThe solar power bank's lithium-ion battery can swell and overheat, posing a burn hazard to consumers.
ActionConsumers should stop using the recalled power banks immediately and visit spectroandco.com/recall to register for a...
Recalled Super Off-Road 12,000 mAh Solar Wireless Power Bank
Limited official informationFood

.155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, 190g 6.70 oz...

The product contains unapproved colors chlorophyll E140 and E141.

Affected.155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging...
RiskThe product contains unapproved colors chlorophyll E140 and E141.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each contai...

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

AffectedAlyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blist...
RiskFailed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results tota...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 2724...

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

AffectedAripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Mad...
RiskProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets U...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication t...

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

AffectedBD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fl...
RiskDue to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or conti...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Insp...

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

AffectedBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product D...
RiskProducts are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of ma...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manu...

Crystallization; identified as Buprenorphine free base

AffectedBuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or I...
RiskCrystallization; identified as Buprenorphine free base
ActionNot available

Missing from associated official evidence: action.