🍎 Food Class I - Dangerous
It was discovered that one batch of sardines were incorrectly labeled - Sardines in Water instead of Sardines in Tomato sauce.
All Recalls
95,038 total recalls in our database
Great Value Macadamia Nuts 4 oz. pouch with UPC CODE: 078742309422 packaged in a cello bag, 6 per case
Texas Star Nut and Food Co.
🍎 Food Class I - Dangerous
One case (out of 4332 cases) of pine nuts was found to have been packed into macadamia nut pouches instead of pine nut pouches.
🍎 Food Class I - Dangerous
Water from a roof leak may have dripped on chips prior to packaging
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Granules India Limited
💊 Drugs Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
💊 Drugs Class I - Dangerous
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
💊 Drugs Class I - Dangerous
Superpotent Drug: Salicylic acid content is above the firm's specification.
🏥 Medical Devices Class I - Dangerous
It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
i-STAT cTnI cartridge
Abbott Point Of Care
🏥 Medical Devices Class I - Dangerous
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Villa Sistemi Medicali S.P.A.
🏥 Medical Devices Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
🏥 Medical Devices Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
🏥 Medical Devices Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
🏥 Medical Devices Class I - Dangerous
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
🏥 Medical Devices Class I - Dangerous
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.