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

Limited official informationPatient-Relevant Medical Devices

Optima XR200amx, Mobile Digital-Ready Radiographic System

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpo...

AffectedOptima XR200amx, Mobile Digital-Ready Radiographic System; Optima XR220amx, Mobile Digital-Ready Radiographic System;...
RiskGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement com...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AffectedOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation dev...
RiskUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Papablic Replacement Brush Heads. Model Number: PAPA317AA.

Potential for brush heads to break.

AffectedPapablic Replacement Brush Heads. Model Number: PAPA317AA.; Papablic Replacement Brush Heads. Model Number: Papablic18B
RiskPotential for brush heads to break.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Photera 600 3-D, phototherapy device

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

AffectedPhotera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders; Photera 400, phototherapy device;...
RiskCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15)

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

AffectedQC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bot...
RiskSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Rapid Refill Continuous Injection System, UPN M00566001

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting sy...

AffectedRapid Refill Continuous Injection System, UPN M00566001
RiskDevices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh...

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may l...

AffectedST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human seru...
RiskThe Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automate...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000

Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and Apr...

AffectedThe Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-u...
RiskGetinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification steril...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Actionable recallConsumer Products

Currey & Company Nottaway Chandeliers

The recalled chandeliers lack proper electrical grounding, posing a risk of serious injury or death from electrocution hazard.

AffectedThis recall involves Currey & Company's Nottaway chandeliers. The iron with brass frame light fixtures were sold in g...
RiskThe recalled chandeliers lack proper electrical grounding, posing a risk of serious injury or death from electrocutio...
ActionConsumers should stop using the recalled chandeliers immediately and contact Currey & Company for a free replacement...
Recalled Currey & Company's Nottaway Chandeliers
Actionable recallConsumer Products

Huish Outdoors Hollis Diving Regulators

The regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.

AffectedThis recall involves Hollis 200LX second stage diving regulators. The regulators are used for Scuba diving and are ma...
RiskThe regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.
ActionConsumers should stop using the recalled diving regulators immediately and return their regulator to the nearest auth...
Recalled Hollis 200LX Second Stage Diving Regulator
Actionable recallConsumer Products

Jobon Torch Lighters Recalled

The lighters violate the mandatory safety standard for multipurpose lighters because they do not have the required child-resistant mechanisms posing a risk of serious injury or death from fire and burn hazards. In addition, the lighters failed to meet the p...

AffectedThis recall involves Jobon butane torch lighters. The lighters have a side ignition trigger and hands-free operation...
RiskThe lighters violate the mandatory safety standard for multipurpose lighters because they do not have the required ch...
ActionConsumers should stop using the recalled lighters immediately and contact Jobon Official Store for a full refund. Con...
Recalled Jobon Butane Torch Lighter
Actionable recallConsumer Products

Liizousuda Paint Thinner Bottles Recalled

The paint thinner contains low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if t...

AffectedThis recall involves Liizousuda paint thinner bottles. The paint thinner comes in a clear bottle with a black cap and...
RiskThe paint thinner contains low-viscosity petroleum distillates, which must be in child-resistant packaging, as requir...
ActionConsumers should secure the recalled paint thinner out of the sight and reach of children immediately and contact She...
Recalled Liizousuda Paint Thinner Bottle
Actionable recallConsumer Products

Madewell Women's Sweaters

The recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or death.

AffectedThis recall involves two styles of Madewell-branded Double V-Neck Pullover and V-Neck Cardigan women's sweaters. The...
RiskThe recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or...
ActionConsumers should stop using the recalled sweaters immediately and contact Madewell for a full refund in the original...
Recalled Madewell Sweater – without buttons
Actionable recallConsumer Products

MNIENT Adult Portable Bed Rails Recalled

The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiat...

AffectedThis recall involves MNIENT-branded adult portable bed rails, model LQX-110055. The recalled bed rails have a white f...
RiskThe recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped...
ActionConsumers should stop using the recalled adult portable bed rails immediately and contact Zhuzhoushizuisuanshangmaoyo...
Recalled MNIENT Adult Portable Bed Rail
Actionable recallConsumer Products

Noerishia Adult Portable Bed Rails Recalled

The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiat...

AffectedThis recall involves Noerishia adult portable bed rails. The bed rails come in black, measure 24 inches wide by 36 in...
RiskThe recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped...
ActionConsumers should stop using the recalled adult portable bed rails immediately and contact Hurzein for a refund. Consu...
Recalled Noerishia Bed Rail (front view)
Actionable recallConsumer Products

Oitnlaughter Projecting Finger Light Toys Recalled

The recalled 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 injuries,...

AffectedThis recall involves Oitnlaughter-branded LED Finger Lights. They were sold in sets of 36 multi-colored lights. Each...
RiskThe recalled finger lights violate the mandatory safety standard for toys because they contain button cell batteries...
ActionConsumers should stop using the recalled toys immediately, take them away from children and contact Delightmi for a f...
Recalled Oitnlaughter LED Projecting Finger Lights
Actionable recallConsumer Products

Panasonic Electric Toaster Ovens

The power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posing a risk of shock and/or fire hazard.

AffectedThis recall involves all Panasonic Electric Toaster Ovens, Model No. NB-G200. The Electric Toaster Ovens are stainles...
RiskThe power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posin...
ActionConsumers should stop using the recalled Electric Toaster Oven immediately and contact Panasonic for a full refund.
Recalled Panasonic Model No. NB-G200 Electric Toaster Oven
Actionable recallConsumer Products

SDADI Kitchen Step Stools Recalled

The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.

AffectedSDADI Kitchen Step Stools are wooden standing towers for kids. The towers were sold under model numbers LT05 and LT01...
RiskThe recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on...
ActionConsumers should stop using the recalled tower stools immediately, store them away from children and contact Yiwushi...
Recalled SDADI Kitchen Step Stool Model LT01
Actionable recallConsumer Products

Target Cat & Jack Children's Sandals

The sandals' decorative pearls can fall off, posing a risk of serious injury or death from a choking hazard.

AffectedThis recall involves Cat & Jack-branded children's sandals. The sandals are tan and have two raffia straps with gold...
RiskThe sandals' decorative pearls can fall off, posing a risk of serious injury or death from a choking hazard.
ActionConsumers should stop using the recalled sandals immediately, take them away from children and contact Target for a f...
Recalled Cat & Jack Toddler Sandal