Recall archive

All consumer recall records

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

Actionable recallConsumer Products

Mangohood Direct Kids Kitchen Standing Towers 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.

AffectedThis recall involves Mangohood Direct-branded children's tower stools, model LT003. The tower stools were sold in nat...
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 and store them away from children until repaired. C...
Recalled Mangohood Kitchen Standing Tower (natural bamboo)
Actionable recallConsumer Products

Mommy's Baby Lovely Deluxe Baby Doll Playsets Recalled

The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts, posing a deadly choking hazard.

AffectedThis recall involves Mommy's Baby Lovely Deluxe Baby Doll Playset, model NEW319A. The recalled playset includes a bab...
RiskThe recalled doll playsets violate the small parts ban because the toys are for children under three years old and so...
ActionConsumers should stop using the recalled toys immediately, take them away from children, and contact TOYHW for a full...
Recalled Baby Doll Playset
Actionable recallConsumer Products

OCOOPA Direct 1.5 Million Rechargeable Hand Warmers

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

AffectedThis recall involves OCOOPA-branded rechargeable lithium-ion battery hand warmers, models UT3053, UT3056, ZLS-118, ZL...
RiskThe lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or deat...
ActionConsumers should stop using the recalled hand warmers immediately and contact OCOOPA Direct for a full refund in the...
Recalled OCOOPA Rechargeable Hand Warmers – models
Actionable recallConsumer Products

of Cpzzkq Baby Loungers Expanded

The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.

AffectedThis recall involves an additional 195 Cpzzkq baby loungers sold in green and purple with "Model No: UMCDB01" printed...
RiskThe recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can...
ActionConsumers should stop using the baby loungers immediately and contact CetoPMax for a refund. Consumers will be asked...
Recalled Cpzzkq Baby Lounger - green
Actionable recallConsumer Products

Trsmima Zipline Kits and Zipline Spring Brakes Recalled

The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not stiff enough to safely slow a rider down and the kit design does not include an emergency brake, posing collision and...

AffectedThis recall involves TT Trsmima Zipline Kits and Heavy Duty Stainless Steel Zipline Spring Brakes. TT Trsmima zipline...
RiskThe zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline...
ActionConsumers should stop using the TT Trsmima zipline kits and zipline spring brakes immediately and contact Trsmima for...
Recalled TT TRSMIMA zipline kit, version with a turnbuckle and waist belt
Actionable recallConsumer Products

Woodure Toddler 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.

AffectedThis recall involves Woodure-branded children's tower kitchen step stools, models WD1764, WD1357, and WD1720. The tow...
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 and store them away from children. Contact Shenzhen...
Recalled Woodure Kitchen Step Stool, Model WD1720
Limited official informationPatient-Relevant Medical Devices

3mensio Workstation (Vascular Fenestrated) software

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user...

Affected3mensio Workstation (Vascular Fenestrated) software
RiskUser measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular struct...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

AffectedAmlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Labo...
RiskFailed Dissolution Specifications; Olmesartan Medoxomil content below specifications
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; howev...

AffectedBoston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing...
RiskSoftware anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calcu...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appl...

Due to device not having FDA Clearance

AffectedBrand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Si...
RiskDue to device not having FDA Clearance
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Brooklyn Roasting Company Pasteurized Cold Brew Concentrate

Ambient storage of the product may lead to Clostridium botulinum toxin formation.

AffectedBrooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box distributed between 04/01/2026 and...
RiskAmbient storage of the product may lead to Clostridium botulinum toxin formation.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Softwa...

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording i...

AffectedEmano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflow...
RiskProblem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio wa...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402...

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, pote...

AffectedFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Ma...
RiskBoston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated w...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

AffectedFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cat...
RiskLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter info...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

AffectedFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cat...
RiskBoston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

AffectedFlexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, RE...
RiskFlexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Ka...

Presence of Particulate Matter: Hair was found in product

AffectedGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose...
RiskPresence of Particulate Matter: Hair was found in product
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes,...

Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.

AffectedGlycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-...
RiskDue to an out-of-specification result for an unidentified impurity detected during routine stability testing.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

AffectedHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
RiskIncorrect concentration of Betadine solution contained within certain AVID convenience kits.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

AffectedHalyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
RiskDefects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intraven...

ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.

AffectedHotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to th...
RiskICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets du...
ActionNot available

Missing from associated official evidence: action.