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

Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syring...

Presence of a Foreign Substance; black particles observed in liquid

AffectedVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers...
RiskPresence of a Foreign Substance; black particles observed in liquid
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

ABC Trading Children's Toys

The recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries can be easily accessed by children, posing a deadly ingestion hazard to children. When button cell a...

AffectedThis recall involves toy headbands and electronic pet cages. The toy headband, model 6300RP, is plastic and has a sma...
RiskThe recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and t...
ActionConsumers should stop using the children's toys immediately and contact ABC Trading for a refund. Consumers will be a...
Recalled Toy Headband - Pink Bow with White Polka Dots
Actionable recallConsumer Products

ABC Trading WSDZ Light-up Glasses

The recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries can be accessed easily by children, posing an ingestion hazard.?Additionally, the packaging and product do not ha...

AffectedThis recall involves WSDZ-branded LED shot glasses. The recalled plastic glasses are clear and have three button cell...
RiskThe recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because...
ActionConsumers should stop using the recalled glasses immediately, place them in an area where children cannot access them...
Recalled WSDZ Light-up Shot Glasses – packaging
Actionable recallConsumer Products

Bethlehem Lights Bethlehem Lights 10-inch Illuminated Ribbon Spheres

The LED lights on the recalled illuminated spheres can overheat, posing a risk of serious injury or death from a fire hazard.

AffectedThe recalled Bethlehem Lights 10-inch Illuminated Ribbon Sphere is a spherical ornament made of reflective, silver-to...
RiskThe LED lights on the recalled illuminated spheres can overheat, posing a risk of serious injury or death from a fire...
ActionConsumers should stop using the recalled illuminated spheres immediately and contact Bethlehem Lights for a full refu...
Recalled Bethlehem Lights 10-inch Ribbon Sphere
Actionable recallConsumer Products

Orb Funkee Squeeze Toys Recalled

The recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse health issues if inhaled.

AffectedThis recall involves two models of Orb Funkee squeeze toys with the date code 3102491A. The products are made of a so...
RiskThe recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse he...
ActionConsumers should take the recalled toys away from children, stop using them immediately and contact The Orb Factory f...
Recalled Orb Funkee Gold Jumbo Monkee (Model 17451)
Actionable recallConsumer Products

PandaEar Portable Hook-On Chairs

The recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch restraints can be removed without the use of a tool and infants can fall through an opening, posing a deadly fall hazard.

AffectedThis recall involves two models of PandaEar portable hook-on chairs. The chairs are used to seat young children at th...
RiskThe recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch re...
ActionConsumers should stop using the recalled portable hook-on chairs immediately and contact PandaEar to receive a full r...
Recalled PandaEar Portable Hook-On Chair, Model BTC-51
Actionable recallConsumer Products

Resistance Bands Recalled

The recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury from impact hazard.

AffectedThis recall involves HomeProGym-branded resistance bands. The latex, stackable bands have a silver metal D?ring at ea...
RiskThe recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury fro...
ActionConsumers should stop using the recalled bands immediately and contact HomeProGym for a full refund or a $50 HomeProG...
Recalled Home Pro Gym Resistance Bands
Limited official informationFood

...And Kimchi branded kimchi

Undeclared allergen ingredient (fish)

Affected...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz...
RiskUndeclared allergen ingredient (fish)
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Alain MILLIAT

Product may contain foreign objects, specifically glass.

AffectedAlain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
RiskProduct may contain foreign objects, specifically glass.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-...

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding...

AffectedArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-...
Risk16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

BARD Dynamic Tip Steerable, Product Number 6DYNTP001

Incomplete seals on sterile product

AffectedBARD Dynamic Tip Steerable, Product Number 6DYNTP001;; BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSE...
RiskIncomplete seals on sterile product
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software...

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "repla...

AffectedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numb...
RiskA software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-142...

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

AffectedBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product...
RiskDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 4...

Crystallization; identified as Buprenorphine free base

AffectedBuprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malv...
RiskCrystallization; identified as Buprenorphine free base
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pa...

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding o...

AffectedCustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic R...
RiskAffected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rota...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the following sized plas...

Foreign object (stainless steel dust/flakes or shreds of plastic)

AffectedDakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the...
RiskForeign object (stainless steel dust/flakes or shreds of plastic)
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Kroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353 4 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella.

AffectedKroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353 4 DISTRIBUTED BY THE KROGER CO., CIN...
RiskPossible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufac...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518...

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture;...

AffectedLVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 2...
RiskStent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or inco...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Medline has identified the presence of particulate within the fluid path of the Manifolds.

AffectedMedline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU D...
RiskMedline has identified the presence of particulate within the fluid path of the Manifolds.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A...

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of ord...

AffectedMedtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following dev...
RiskSoftware issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps s...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Ver...

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

AffectedOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medic...
RiskLack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observatio...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

AffectedOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
RiskHeart valves were released and distributed before all required testing was complete, so it cannot be confirmed that t...
ActionNot available

Missing from associated official evidence: action, consumer scope.