Complete FDA and NHTSA recall records dated in August 2022.
These records include useful source details for the selected month.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Hyundai Motor America (Hyundai) is recalling 2020-2022 Palisade vehicles potentially equipped with a tow hitch harness installed as original equipment, or purchased as an accessory through…
Hyundai Motor America (Hyundai) is recalling certain 2022 Elantra N and 2022-2023 Elantra vehicles. The emblem on the cover of the driver's front air bag may not have been welded properly,…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an…
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1,…
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic…
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery,…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
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.
