2023 Product Recalls
0 recalls issued in 2023.
Propane Leak May Cause Fire
A propane leak in the presence of an ignition source can increase the risk of a fire.
Dealers will inspect and if necessary, replace the service valves, free of charge. The manufacturer has not yet provided a schedule for recall notification. Owners may contact Adventurer customer service at 1-509-895-7064.
Bicycle handlebars and bicycles Recalled for Crash Hazard
The recalled handlebars can crack where the brake/shift levers are installed and cause a crash, posing an injury hazard.
Consumers should immediately stop using the recalled handlebars and bicycles, and bring the recalled handlebars and bicycles to a local bicycle retailer for free installation of a replacement carbon handlebar or an alternative aluminum handlebar.
Model Year 2020-2023 Sportsman 1000 S and Scrambler 100 Recalled for Fire Hazard
Electrostatic discharge outside the fuel tank can ignite fuel spills while refueling, posing a fire hazard.
Consumers should immediately stop using the recalled vehicles and contact a Polaris dealer to schedule a free repair. Polaris will instruct dealers to install new fuel filler neck clamps and, if needed, a fill neck cover. Polaris has notified consumers to stop riding the vehicles and is contacting registered owners directly to provide more details about the repair.
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Bottles Missing Product Label
Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
A Recall notification letter titled, "Medical Device Removal - Immediate Action Required" was sent to the OUS consignees on 03/05/2021 and the U.S. consignees on 03/08/2021 via overnight mail delivery. Customers outside of the US were either contacted via letter delivery or email. The recalling firm requested if the consignees identify any product from the listed batch within their inventory, to please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. The consignees will receive replacement product for all removed product returned to Boston Scientific. Distributors are also informed in the letter that the removal depth is to the hospital level and the removal notification should be forwarded to their customers. The field removal letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating they have received the field removal and followed the included instructions.
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.
On 03/17/2021, Stryker issued an Urgent Medical Device Recall notice to customers and distributers via letter because the firm identified non-conforming components of the Titanium X TL sets which could lead to device failure in the field.
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
In May, 2021, Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" notice to customers via letter notifying them Medtronic is voluntarily recalling certain lots of Angiographic Guidewire components. In June 2021, Medtronic issued AMENDED URGENT MEDICAL DEVICE RECALL notices to customers. On The component part numbers associated with this recall are intended for shipment to a third-party, where they are further processed into kits and sterilized, but were instead shipped directly to customers. Actions: Medtronic records indicate that your facility has received one or more of the affected Angiographic Guidewire components. As a result, Medtronic requests that you immediately take the following actions: -Identify and quarantine all unused affected components identified in the customer letter. -Utilize standard hospital practice and policies to notify patients who were treated with the recalled components. -Return/Exchange all unused affected components in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-716-6700 to initiate a component return/exchange. Your local Medtronic Representative can assist you in the return of this component. Please refer to Table 2 for applicable part numbers to facilitate reordering. -Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. If you have any questions regarding this communication, please contact your Medtronic Field Representative or call:763-526 -8583 or email: rs.cvgrecalls@medtronic.com.
Children's pajamas Recalled for Burn Hazard
The recalled children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Consumers should immediately take the recalled pajamas away from children, stop using them and contact P.J. Salvage for instructions on how to receive a pre-paid mailer and return the pajamas for a full refund. Consumers who purchased the pajamas directly from P.J. Salvage will be contacted via email and/or postage mail.
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
XO Marshmallow Limited Edition: Banana Puddin' OMG (Ooey Marshmallow Goodness), 12oz. marshmallow fluff, 4 12oz. retail units per case
No label on packaged product
Premium Quality Shirakiku Fish Sausage Jalapeno Net wt. 9.8 oz. (280g) UPC 074410366421 Ingredients: Fish meat (bream, sugar, sodium tripolyphosphate, wheat starch, corn oil, less than 1.5% of salt, soy protein, sugar, maltodextrin, onion powder, garlic powder, yeast extract, disodium inosinate, disodium guamylate, oleoresin black pepper, garlic oil, onion oil, nutmeg oil, corn starch, monosodium glutamate, jalapeno, paprika extract, dextrose anhydrous, d-xylose, dried ginger, oleoresin ginger
Undeclared collagen (bovine dermis) casing
"Lukai sweetened jujube"; 8.3 ounces; red and yellow packaging; back panel states: "Name: Ejiao dates; Ingredients: a nuclear-free golden jujube, donkey-hide gelatin, sugar, honey, maltose, citric acid; Consumption methods: open bags of ready-to-eat, soup, making cakes; Shelf life: 12 months; Place of Origin: China Chengdu; Storage: Please store in a dry well-ventilated place, or frozen better; American General Agency: NORTHERN FOOD I/E INC"
Product contains undeclared sulfites (17.9mg/serving).
Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date) UPC: 8 3765448372 5
Product found to contain wheat that is not declared on the label.
Favorina Advent Calendar NET WT. 8.4OZ (240g) Premium Chocolate with a Creamy Filling UPC 4056489516965
Potential Salmonella contamination.
Premium Quality Shirakiku Fish Sausage Original Net wt. 9.8 oz. (280g) UPC 074410366414 Ingredients: Fish meat (bream, sugar, sodium tripolyphosphate, wheat starch, corn oil, less than 1.5% of salt, soy protein, sugar, maltodextrin, onion powder, garlic powder, yeast extract, disodium inosinate, disodium guamylate, oleoresin black pepper, garlic oil, onion oil, nutmeg oil, corn starch, monosodium glutamate, dextrose anhydrous, d-xylose, sodium tripolyphosphate, glucose, ginger extract, cochine
Undeclared collagen (bovine dermis) casing
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
The recalling firm issued an Advisory Notice Information dated 2020-06-30 on 7/2/2021 via email which explained the reason for recall and that they would be contacted as soon as possible to proceed with the exchange. On 9/24/2021, a Returned Goods Authorization Form was sent to the consignees so the adapter could be exchanged.
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.
Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.