The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
All Recalls
95,038 total recalls in our database
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Luminex Molecular Diagnostics
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
Potential for the wire to fracture at the threads and remain in the glenoid.
Rifton E-Pacer, SKU K660, powered lift device
Community Products
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
ICU Medical
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Beckman Coulter
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
Life Technologies Holdings Pte
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Beckman Coulter
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Andover Healthcare
Incomplete packaging seal of sterile product
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
OMNIlife science
Stems missing porous coating on the device.
MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
CrossRoads Extremity Systems
Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Andover Healthcare
Incomplete packaging seal of sterile product
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Lawn Mower Engines
Kawasaki Motors Manufacturing Corp. U.S.A., of Maryville, Mo.
The high pressure fuel line can get damaged causing a fuel leak, posing burn and fire hazards.
Coastline Ceramic Mugs
Unknown Manufacturer
The mugs can crack or break when used with or exposed to hot liquids, posing burn and laceration hazards.
Bead Landingβ’ tassel keychain mobile power banks
Unknown Manufacturer
The lithium ion battery in the keychain's mobile power bank can overheat, posing fire and burn hazards.
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
Products were labeled with incorrect ingredient listing. The ingredients listed on the label include multiple allergens (almonds, cashews, coconut, hazelnuts, pecans, walnuts, peanuts). Label lists allergens that are not actually in the product. Allergens actually present in the product are: peanuts, almonds, cashews, coconut, hazelnuts, walnuts.