NOVACAB SAPI DE CV Suspiros German Cake recall — FDA H-0345-2025
Multiple cake products contain goat milk, which was labeled as "milk"
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Multiple cake products contain goat milk, which was labeled as "milk"
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary…
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity,…
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during…
Due to defects (bubbles/voids) identified during standard finished goods testing
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting…
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during…
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by…
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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