All consumer recall records

Medtronic Harmony Delivery Catheter System

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

Missing from associated official evidence: action.

MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER CAPSULE, SUPPLEMENT FACTS...

Product may be contaminated with Salmonella Typhimurium

Missing from associated official evidence: action.

MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable plastic bag...

Potential contamination with plastic material

Missing from associated official evidence: action.

Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9

Dietary supplement product Ocular Plus contains undeclared Yellow#5.

Missing from associated official evidence: action.

Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (...

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an exter...

Missing from associated official evidence: action, consumer scope.

Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041

Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)

Missing from associated official evidence: action.

Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A...

Elevated coliforms

Missing from associated official evidence: action.

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02)

Presence of Foreign Substance

Missing from associated official evidence: action.

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive ala...

Missing from associated official evidence: action, consumer scope.

RayCare 2024A SP1. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

Missing from associated official evidence: action, consumer scope.

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiolo...

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...

Missing from associated official evidence: action.

Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine L...

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Missing from associated official evidence: action.

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, N...

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Missing from associated official evidence: action.

Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.1...

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may i...

Missing from associated official evidence: action, consumer scope.

Solar GI System (Water Perfusion)

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may a...

Missing from associated official evidence: action, consumer scope.

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, D...

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Missing from associated official evidence: action.

SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston

A single lot of expired syringes were distributed due to a distribution system control failure.

Missing from associated official evidence: action, consumer scope.

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lo...

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Missing from associated official evidence: action.

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured f...

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

Missing from associated official evidence: action.

Vista MAX

Dietary supplement product Vista MAX contains undeclared Yellow#5.

Missing from associated official evidence: action.

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Missing from associated official evidence: action, consumer scope.

AMASKY Nursing Pillows Recalled

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...

Conair Over One Million Cuisinart Grill Brushes

Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.

Cooper Lighting Metalux Optimized High Bay LED Light Fixtures

The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard.