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 informationDrugs

Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick,...

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

AffectedXyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories...
RiskLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick,...

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

AffectedXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories...
RiskLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Yunker(branded) Energy & Health Herbal Supplement with Vitamins

Product does not meet label claim for Vitamin E.

AffectedYunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml...
RiskProduct does not meet label claim for Vitamin E.
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

Bicycle Helmets Recalled

The recalled helmets violate the mandatory safety standard for?bicycle helmets?because the helmets do not comply with the impact attenuation and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious r...

AffectedThis recall involves Gudook-branded bicycle helmets, model KY-055. The helmets were sold in blue with white and in si...
RiskThe recalled helmets violate the mandatory safety standard for?bicycle helmets?because the helmets do not comply with...
ActionConsumers should stop using the helmets immediately and contact Gudook Outdoor Sports for a full refund. Consumers wi...
Recall Gudook Bicycle Helmet
Actionable recallConsumer Products

Crenlux Pool Drain Covers Recalled

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

AffectedThis recall involves Crenlux-branded pool drain covers. The white plastic pool drain covers measure about eight inche...
RiskThe recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safet...
ActionPool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately and...
Recalled Crenlux Pool Drain Cover
Actionable recallConsumer Products

Little Grape Land Nursing Pillows

The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows?and infant support cushions?because they can obstruct an infant's breathing, posing a serious risk of injury or death from s...

AffectedThis recall involves Little Grape Land Nursing Pillows. The nursing pillows are U-shaped and come in a rose floral, a...
RiskThe recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for...
ActionConsumers should stop using the recalled nursing pillows immediately and contact Little Grape Land for a full refund....
Recalled Little Grape Land Nursing Pillow - rose floral
Actionable recallConsumer Products

Pool Drain Covers Recalled

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

AffectedThis recall involves Broqixin-branded pool drain covers. The white plastic pool drain covers measure about 7.36 inche...
RiskThe recalled drain covers violate the entrapment protection standards of the?Virginia Graeme Baker Pool and Spa Safet...
ActionPool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately and...
Recalled Broqixin Pool Drain Cover
Actionable recallConsumer Products

SUNS International Residential Elevator Interlock Switches

The affected interlock switches can become stuck in a retracted position, allowing the exterior door to remain unlocked, posing a risk of death or serious injury if the elevator is called to another floor.

AffectedThis recall involves all SUNS International SS6291 Solenoid Interlock switches used in residential elevators produced...
RiskThe affected interlock switches can become stuck in a retracted position, allowing the exterior door to remain unlock...
ActionConsumers should stop using their residential elevator containing the SUNS interlock switch immediately and contact S...
Recalled SUNS SS6291 Solenoid Interlock Switch
Actionable recallConsumer Products

Tiny Land Children's Play Tents Recalled

The recalled tents' fiberglass poles can shed fibers, posing an injury risk of skin and eye irritation.

AffectedThis recall involves Tiny Land-branded children's play tents. The play tents are made of a cream-colored fabric and h...
RiskThe recalled tents' fiberglass poles can shed fibers, posing an injury risk of skin and eye irritation.
ActionConsumers should stop using the tents immediately, disassemble the tents and place the poles in an area where childre...
Recalled Tiny Land Play Tent
Actionable recallConsumer Products

TOMY Boon NURSH 8 oz Reusable Baby Bottles

The hard plastic outer shell can bubble or partially peel off, resulting in loose pieces of film-like plastic that pose a choking hazard to young children.

AffectedThis recall involves Boon NURSH 8 oz Reusable Baby Bottles 3-Pack in pink tie dye. The recalled bottles were sold in...
RiskThe hard plastic outer shell can bubble or partially peel off, resulting in loose pieces of film-like plastic that po...
ActionConsumers should stop using the recalled baby bottles immediately and contact TOMY to receive a refund in the form of...
Recalled Boon NURSH 8 oz Reusable Baby Bottles in Pink Tie Dye
Actionable recallConsumer Products

Vornado Air SRTH Small Room Tower Heaters

The recalled heater's fan blade can detach from the motor shaft, which can cause the fan to slow or stop, leading to overheating and melting of the enclosure and internal parts. Melted internal parts can ignite and breach the enclosure if the thermal cut of...

AffectedThe recalled Vornado SRTH small room tower heaters were sold in black and white and measure about 12.5 inches high by...
RiskThe recalled heater's fan blade can detach from the motor shaft, which can cause the fan to slow or stop, leading to...
ActionConsumers should stop using the recalled heaters immediately and contact Vornado for instructions on how to submit ph...
Recalled SRTH Small Room Tower Heater
Actionable recallConsumer Products

Wyze Labs Solar Cam Pan Security Cameras

The recalled Wyze Solar Cam Pan security cameras' incorrect assembly instructions can lead consumers to accidentally puncture the lithium?ion battery's metal casing, causing the battery to rapidly overheat, posing a risk of serious injury or property damage...

AffectedThe recalled Wyze Solar Cam Pan are lithium-ion battery operated outdoor security cameras. The products are wire-free...
RiskThe recalled Wyze Solar Cam Pan security cameras' incorrect assembly instructions can lead consumers to accidentally...
ActionConsumers should stop using the recalled Wyze Solar Cam Pan security camera immediately and visit http://www.wyze.com...
Recalled Wyze Solar Cam Pan Security Cameras
Limited official informationFood

(BULK) SPL-BEV Banana CWT (Banana Smoothie)

Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.

Affected(BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099
RiskFirm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Automated Impella Controller (AIC)

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received ser...

AffectedAutomated Impella Controller (AIC); Product Code: 0042-0000-US;
RiskA retrospective review identified that there are AIC units requiring specific hardware updates to address potential s...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette a...

AffectedAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Co...
RiskRetrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risk...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Azurion system

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is inst...

AffectedAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 72222...
RiskIt was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166.

Products were made with recalled California Dairies milk powder due to Salmonella.

AffectedButter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Wauk...
RiskProducts were made with recalled California Dairies milk powder due to Salmonella.
ActionNot available

Missing from associated official evidence: action.