Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
All Recalls
95,089 total recalls in our database
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Encore Medical
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Randox Laboratories
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
DR Power Chipper Shredders
Generac Power Systems Inc., of Waukesha, Wisconsin
Pieces of metal can come loose from inside the shredder's housing and be ejected, posing a laceration hazard. Also, the hopper can become detached from the shredder, posing a laceration hazard.
Novaform ComfortGrande 14-inch and Novaform DreamAway 8-inch Mattresses
FXI Inc., of Radnor, Pennsylvania
The mattresses could have been exposed to water during the manufacturing process allowing mold to develop and posing a health risk to individuals with compromised immune systems, damaged lungs or an allergy to mold.
Men's clasp beaded bracelets
Unknown Manufacturer
The clasp on the beaded bracelet contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.
HONEY JOY Infant Swings
Unknown Manufacturer
The swing violates the Safe Sleep for Babies Act because the product was marketed for infant sleep and has an incline angle greater than 10 degrees. Infant fatalities have occurred in inclined sleepers, after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances. The swing also violates the Safety Standard for Infant Swings.
Rainbow Road Series Board Books
Unknown Manufacturer
The plastic binding rings can detach from the books, posing a choking hazard to young children.
11-Speed Bonded Hollowtech II Road Cranksets
Unknown Manufacturer
The recalled bonded crank parts can separate and break, posing a crash hazard to consumers.
Plastic foreign object found in product.
La Reyna Salsa Roja, Gluten Free / Medium. Product Code 1783. Net Wt 16 oz. UPC 7 52830-92630 1. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
Twin Cities Co-Op Partners
Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.
Listeria monocytogenes
Undeclared Allergen - Soy Flour
Undeclared egg
Listeria monocytogenes
Zespri Organic Green Kiwi, product of New Zealand, one pallet of bulk loose organic green kiwifruit was shipped to one consignee in Chicago, IL. The master carton has the barcode 067834 and the kiwi PLU label has the code GTIN 9400 9552.
David Oppenheimer & Company I
Listeria monocytogenes
US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
Killer Brownie
Foreign Material - Plastic