All Recalls

95,025 total recalls in our database

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Aug 24, 2020 Prescription Drugs Nationwide View Details β†’

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Aug 24, 2020 Prescription Drugs Nationwide View Details β†’

CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.

Jul 9, 2020 Other Drugs Nationwide View Details β†’

PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

MicroPort Orthopedics

πŸ₯ Medical Devices Class I - Dangerous

MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMURΒΏ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMURΒΏ Hip System Package Insert with the most recent revision (150803-8).

Jul 31, 2020 Implants & Prosthetics Nationwide View Details β†’

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

Aug 4, 2020 Infusion Pumps Nationwide View Details β†’

US-dates between the product package label and the bar code display.

Jul 15, 2020 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Aug 4, 2020 Other Medical Devices Nationwide View Details β†’

The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.

Aug 6, 2020 Other Medical Devices Nationwide View Details β†’

SICAT IMPLANT V2.0

SICAT GMBH & CO. KG

πŸ₯ Medical Devices Class I - Dangerous

A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

Jul 15, 2020 Implants & Prosthetics View Details β†’

There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.

Jul 15, 2020 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

Jun 10, 2020 Surgical Instruments View Details β†’