Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing…
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
There is a risk that the device can start a fire if flammable liquids contact and enter the device.
Non-sterile product was shipped to customers labelled as sterile.
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if…
Due to the release of nonconforming Intraocular Lenses (IOLs).
Firm discovered that labeling had been switched for two products on one day of production - undeclared almonds and cashews.
Undeclared ingredients on retail packaging, including but not limited to certified colors Red #40 and Blue #1
Firm discovered that labeling had been switched for two products on one day of production - undeclared almonds and cashews.
Products are potentially contaminated with Salmonella.
Possible contamination with Cyclospora in basil
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Defective Delivery System: Out of specification for mechanical peel.
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Browse recent months with enough recall history for useful comparison.
