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

TOMY Boon PIVOT Collapsible Toddler Tower Kitchen Step Stools

The recalled toddler towers can tip over while in use, posing a risk of serious injury and death, due to tip over and fall hazards.

AffectedThis recall involves Boon PIVOT Toddler Tower Kids Kitchen Step Stools. The metal and plastic tower stools were sold...
RiskThe recalled toddler towers can tip over while in use, posing a risk of serious injury and death, due to tip over and...
ActionConsumers should stop using the recalled tower stools immediately and store them away from children until repaired. C...
Recalled Boon PIVOT Toddler Tower Kitchen Step Stool (Gray)
Actionable recallConsumer Products

Wade Logan Annyka 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 risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.

AffectedThis recall involves Wade Logan Annyka 9-Drawer Fabric Dressers. The recalled dressers are made of fabric and a metal...
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 Wade Logan Annyka 9-Drawer Fabric Dresser (front)
Actionable recallConsumer Products

Warren James the Copper Cup Found in Flashgitz Relic Lunch Boxes

The cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning hazard. Lead is toxic if ingested by adults or children and can cause adverse health issues.

AffectedThis recall involves the copper cup found in the Flashgitz-branded Space King No Girls Allowed Relic Lunch Boxes. The...
RiskThe cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning haza...
ActionConsumers should stop using the recalled cups immediately and contact the firm for instructions on how to receive a r...
Recalled Space King No Girls Allowed Relic Lunch Box (Front)
Limited official informationPatient-Relevant Medical Devices

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing...

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Affected5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush S...
RiskPotential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the su...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Surgical dressing manufactured out of specification (greater thickness).

AffectedAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
RiskSurgical dressing manufactured out of specification (greater thickness).
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

AffectedAtellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
RiskThe potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis kn...

Due to packaging discrepancy with incorrect product size mixed up.

AffectedBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product De...
RiskDue to packaging discrepancy with incorrect product size mixed up.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fl...

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

AffectedBrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product...
RiskDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchet...

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

AffectedBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Softwa...
RiskSecure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufacture...

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

AffectedFresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000...
RiskRaw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Ra...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufactured By LPK1 Renton, WA...

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

AffectedFresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufacture...
RiskRaw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded c...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE...

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

AffectedGSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GA...
RiskReduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and co...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear...

Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.

AffectedHigh Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product i...
RiskUndeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-pac...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV003...

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

AffectedIntracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUME...
RiskIntraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may intr...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

A product error defect may cause incorrect bracket placement.

AffectedKL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
RiskA product error defect may cause incorrect bracket placement.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution co...

AffectedMedline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A; Medline Convenience Kits: 1) OPEN...
RiskConvenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a re...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 8009...

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

AffectedMedline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive,...
RiskFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Ins...

AffectedMiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
RiskA software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached...

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

AffectedOlympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- desi...
RiskOlympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design o...
ActionNot available

Missing from associated official evidence: action, consumer scope.