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 informationFood

Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers packed into "Wonton Noodles...

No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.

AffectedWonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers packed...
RiskNo labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

12-Drawer Fabric Dressers Recalled

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY...

AffectedThis recall involves Romorgniz 12-Drawer Fabric Dressers. The recalled dressers come in white, brown, and black. The...
RiskThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that...
ActionConsumers should stop using the recalled dressers if they are not anchored to the wall immediately and place them in...
Recalled Romorgniz 12-Drawer Fabric Dresser (front)
Actionable recallConsumer Products

Aojieni Silicone Sili Factory 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 Aojieni Silicone pull string teething toys. The teething toys consist of a pink disc shape with...
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 Aojieni Silicone to...
Recalled Sili Factory Pull String Teething Toy
Actionable recallConsumer Products

CuddleCubs Creations Teething Toy Sets Recalled

The recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of a child's throat and become lodged, posing...

AffectedThis recall involves the CuddleCubs Creations highchair teething toy set, colors "BlueOrange" and "YellowOrange". The...
RiskThe recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys becau...
ActionConsumers should stop using the pull string teething toys immediately, take them away from children and contact YouRf...
Recalled CuddleCubs Creation Baby Highchair Teething Toy Set, Color "BlueOrange" (Pull String Teething Toy on right)
Actionable recallConsumer Products

EnHomee 9-Drawer Fabric Dressers Recalled

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.

AffectedThis recall involves EnHomee 9-Drawer Fabric Dressers. The recalled dressers come in white, brown, gray, and black. T...
RiskThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that...
ActionConsumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in...
Recalled EnHomee 9-Drawer Fabric Dresser (front)
Actionable recallConsumer Products

OeyUoc 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 consumers.

AffectedThis recall involves the OeyUoc white pool drain cover, sold as a replacement pool drain cover for swimming pools. Th...
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 cover immediately and...
Recalled OeyUoc Pool Drain Cover
Actionable recallConsumer Products

Peony Design Personalized Baby Bibs and Stroller Bags

The snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking hazard to young children.

AffectedThis recall involves Peony Design personalized handmade baby bibs and stroller bags. The bibs have scalloped edges, a...
RiskThe snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking...
ActionConsumers should take the recalled baby bibs and stroller bags away from children immediately, stop using them, and c...
Recalled bib with strawberry print
Actionable recallConsumer Products

Sviyatp 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 consumers.

AffectedThis recall involves the Sviyatp white pool drain cover, sold as a replacement pool drain cover for swimming pools. T...
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 Sviyatp Pool Drain Cover with two screws
Limited official informationPatient-Relevant Medical Devices

ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. hear...

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in ever...

AffectedABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product...
RiskA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. hear...

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

AffectedAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F...
RiskDue to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm,...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)...

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

AffectedBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/cart...
RiskLack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the appli...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large...

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

AffectedBrand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Med...
RiskPackaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an...

Affectedda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
RiskRobotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape ri...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 5785...

Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.

Affectedfunctional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (3...
RiskSubpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitam...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

General Biospy Tray, REF: GUTS1000

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

AffectedGeneral Biospy Tray, REF: GUTS1000; Arterial Line Kit 20ga x 6, REF: 400115A; plus 4 additional official variants lis...
RiskKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meet...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

AffectedIce Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548; Ice Pop, D'Dioses Tamarindo, 1 Bar (81.7 g), with UPC...
RiskMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

AffectedICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump; ICU...
RiskIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readi...

AffectedMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267; Medline Kits containing Zi...
RiskKits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present r...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

AffectedMedtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula; Medtr...
RiskMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-05...

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

AffectedNystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham,...
RiskSubpotent Drug: Low out of specification assay results performed during long-term stability testing.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

AffectedOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.; Olympus Toomey...
RiskSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and ther...
ActionNot available

Missing from associated official evidence: action, consumer scope.