Complete FDA and NHTSA recall records dated in July 2020.
These records include useful source details for the selected month.
Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the…
Potential risk of patient mix-up on analyzers due to software issues.
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Lack of pouch seal. Product is labelled as sterile.
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one…
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the…
Lack of pouch seal. Product is labelled as sterile.
A foreign object found by a consumer in dark chocolate bar.
The firm learned that, during a single production run, incorrect condiment packets were placed into Southwest Chopped Kit bags and, as a result, the allergens wheat, soy, cashews, and…
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode…
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant…
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
