Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient
All Recalls
95,114 total recalls in our database
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Fresenius Medical Care Holdings
Bottles Missing Product Label
Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
The Binding Site Group
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Baxter Healthcare
Potential for the battery to lose its ability to be recharged.
Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Riverpoint Medical
Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
SARS-CoV-2 Antigen Test
Qiagen Sciences
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Missing Instruction For Use insert.
CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
Muscle Rack Heavy Duty Steel Shelving Units
Edsal Manufacturing Company, of Chicago, Ill.
The shelves can fail to support the 800-pound weight load as stated on the packaging, posing an injury hazard to the consumer.
Bowflex SelectTechβ’ 2080 Barbells with Curl Bar
Unknown Manufacturer
A weight plate can fall from the end of the barbell, posing an impact injury hazard.
Klein s Cookies and Cream Bulk Packaged in a 3 gallon paper drum.
Weis Markets, Inc., Ice Cream Division
Ice Cream product may contain metal (foreign objects).
Cinnamon Walnut Coffee Cake, Item 258, Net Wt. 24 oz.
Nueske Applewood Smoked Meat
Coffee cake may contain undeclared wheat, egg, milk, and walnuts.
Klein s Vanilla Ice Cream. Packaged in a 3 gallon paper drum.
Weis Markets, Inc., Ice Cream Division
Ice Cream product may contain metal (foreign objects).
Frozen pizza crust may contain foreign material (glass).