DrugMay 23, 2018
Apotex Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use recall — FDA D-0839-2018
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class IFDA: TerminatedApotex Inc.
May 2018 recalls — page 8
These records include useful source details for the selected month.
DrugMay 23, 2018
Prescript Pharmaceuticals Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP recall — FDA D-0809-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers recall — FDA D-0806-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Apotex Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use recall — FDA D-0840-2018
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class IFDA: TerminatedApotex Inc.
VehicleMay 17, 2018
Chrysler wiring recall — NHTSA campaign 18V332000
Chrysler (FCA US LLC) is recalling certain 2014-2018 Dodge Journey, Charger and Durango, RAM 2500, 3500, 3500 Cab Chassis (more than 10,000lb), 4500 Cab Chassis and 5500 Cab Chassis, Jeep…
wiringChrysler (FCA US LLC)
Medical DeviceMay 16, 2018
Ninepoint Medical NvisionVLE Low-Profile Optical Probe recall — FDA Z-1781-2018
Distal tips of the probes may detach from the probe shaft during use.
Class IIFDA: TerminatedNinepoint Medical Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1559-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Deerfield Imaging IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative recall — FDA Z-1645-2018
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the…
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics ADVIA Centaur Folate (FOL) recall — FDA Z-1689-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1739-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage recall — FDA Z-1547-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Datascope BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 recall — FDA Z-1723-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1734-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs recall — FDA Z-1552-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Boston Scientific Capio RP; Model #M0068321010. Intended for use in general suturing recall — FDA Z-1621-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Siemens Medical Solutions USA ACUSON SC2000 Ultrasound System recall — FDA Z-1200-2018
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 16, 2018
Parker Laboratories Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model recall — FDA Z-1777-2018
There is a potential for the gel packets to have leaks in the packet seal.
Class IIFDA: TerminatedParker Laboratories, Inc.
Medical DeviceMay 16, 2018
PerkinElmer Life and Analytical Sciences NeoBase Succinylacetone Assay Solution, Product recall — FDA Z-1692-2018
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking…
Class IIFDA: TerminatedPerkinElmer Life and Analytical Sciences, Wallac, OY
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product recall — FDA Z-1550-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for recall — FDA Z-1795-2018
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Class IIFDA: TerminatedTP Orthodontics, Inc.
Medical DeviceMay 16, 2018
Boston Scientific Capio SLIM Suture Capturing Device, Model #M0068318250 recall — FDA Z-1616-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Datascope BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. recall — FDA Z-1720-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Datascope Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513 recall — FDA Z-1707-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Vista Ammonia (AMM) assay recall — FDA Z-1655-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
How to use this monthly recall archive
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.