Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart…
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount…
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message,…
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart…
During sanitation activities it was noticed that two light shields had pieces missing and potentially could have gotten into finished products.
Potato Buns label declares "Contains: wheat, dairy". Milk is declared in the ingredients statement, but not in the Contains statement.
Hot Dog Buns label declares "Contains: wheat, egg, dairy". Milk is declared in the ingredients statement, but not in the Contains statement.
Condies Foods is recalling Veggie Cups due to undeclared milk and egg.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine…
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Lack Of Assurance Of Sterility
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Microbial Contamination of Non-Sterile Products.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
