Archive
1,113 recalls were announced in May 2018.
Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 27% are Severe.
Which agencies issued them
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.
Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.
Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.
Kroger Specialty Pharmacy is recalling Tecfidera 240 mg capsules due to a lack of processing controls. The affected units were dispensed in five states.
Kroger Specialty Pharmacy is recalling Creon DR 24,000 Units capsules due to a lack of processing controls. The affected products were dispensed in five states.
Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.
Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.
Bard Peripheral Vascular Inc is recalling 383 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Beaver-Visitec International Inc. is recalling 1,025 units of Wet-Field Hemostatic Eraser Bipolar 25G instruments because they were packaged with incorrect labeling.
Grato Holdings is recalling Peaceful Mountain Nasal Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Kroger Specialty Pharmacy is recalling Boost VHC Oral Liquid due to a lack of processing controls. The product was distributed in five states.
Kroger Specialty Pharmacy is recalling Sutent 50 mg capsules due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Kroger Specialty Pharmacy is recalling Otezla 30 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Revlimid 5 mg oral capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Taltz 80 mg/mL pens distributed in five states due to a lack of processing controls.
Bard Peripheral Vascular Inc is recalling 15 units of POWERPORT ClearVUE isp Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Bethkis 300 mg/4 mL ampules due to a lack of processing controls. The affected product was distributed in five states.
Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.
Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.
Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Hyphen BioMed is recalling 12 ZYMUTEST HIA MonoStrip IgG kits because the package insert incorrectly lists serum and other fluids as valid sample types.
Bard Peripheral Vascular Inc is recalling POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Kisqali 200 mg tablets dispensed in five states due to a lack of processing controls.
Grato Holdings, Inc. is recalling Energique Enervimin CNCR Focus dietary supplements because they are unapproved new drugs based on disease claims.
Kroger Specialty Pharmacy is recalling Kalydeco 150 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling OPDIVO 40 mg/4 mL SDV due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
Kroger Specialty Pharmacy is recalling Revlimid 15 mg oral capsules due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Straumann Manufacturing is recalling Emdogain Enamel Matrix Derivative because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.
Kroger Specialty Pharmacy is recalling Xalkori 250 mg capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Promacta 50 mg tablets due to a lack of processing controls. The recall affects specific lots dispensed in five states.
Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.
MHC Medical Products LLC is recalling EasyTouch Insulin Syringes because retail cartons may display incorrect lot numbers.
Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.
Bard Peripheral Vascular Inc is recalling 4,044 POWERPORT ClearVUE catheters because the Patient ID Card contains incorrect port flushing instructions.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.
Kroger Specialty Pharmacy is recalling Stelara 90 mg/MI PFS due to lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.
Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.
Kroger Specialty Pharmacy is recalling Ibrance 125 mg capsules due to a lack of processing controls. The recall covers units dispensed in five states between December 2017 and February 2018.
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive may not stick well to the skin.
Kroger Specialty Pharmacy is recalling Altera Handset due to a lack of processing controls. The product was distributed in five states.
Kroger Specialty Pharmacy is recalling Sodium Chloride 3% Inhalation Solution due to a lack of processing controls. The product was distributed in five states.
Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.
Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.
Siemens Healthcare Diagnostics is recalling IMMULITE CA125 assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.
Bard Peripheral Vascular Inc is recalling 876 units of POWERPORT ClearVUE Implantable Ports because the packaged Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Praluent 75 mg pens due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Polyethylene Glycol 3350 powder for solution due to a lack of processing controls. The product was distributed in five states.
Munk Pack Inc. is recalling specific lots of Protein Cookies due to mold growth. Consumers should check their pantry and discard affected products.
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.
Munk Pack Inc. is recalling specific lots of Double Dark Chocolate Protein Cookies due to mold growth. Consumers should check their pantry and discard affected products.
Bard Peripheral Vascular Inc is recalling 2,395 units of POWERPORT ClearVUE isp catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Sutent 37.5 mg capsules due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Letrozole 2.5 mg tablets dispensed between December 2017 and February 2018 due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Zarxio 300 mcg/0.5 mL PFS due to lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Xolair 150 mg SDV due to a lack of processing controls. The affected products were dispensed in five states.
Kroger Specialty Pharmacy is recalling Sprycel 80 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Gleevec 100 mg tablets dispensed in five states due to a lack of processing controls.
Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.
Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.
Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.
Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.
Kroger Specialty Pharmacy is recalling Copaxone 20 mg Injection PFS due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018 in five states.
Kroger Specialty Pharmacy is recalling Enbrel PFS 50 mg/mL injections due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling Dimension Vista Cardiac Troponin I reagent cartridges because they are susceptible to interference from biotin, which is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Revlimid 25 mg oral capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Cimzia 200 mg/mL PFS Kits due to a lack of processing controls. The affected lots were dispensed in five states.
Kroger Specialty Pharmacy is recalling Cyclophosphamide 50 mg capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur DHEA-SO4 kits because the instructions for use incorrectly state the level at which biotin does not interfere.
Kroger Specialty Pharmacy is recalling Humira Pen Sub-q and Psor Kits due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Cosentyx 150 mg/mL prefilled syringes due to a lack of processing controls. The recall affects specific lots dispensed in five states.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin interference is not documented in the instructions, potentially affecting test accuracy.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Temozolomide 250 mg capsules due to a lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Dupixent 300 mg/2 mL prefilled syringes due to a lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.
Kroger Specialty Pharmacy is recalling Prolia 60 mg/1 mL syringes due to a lack of processing controls. The affected units were dispensed in five states.
Diagnostic Hybrids, Inc. is recalling 1004 units of the MicroVue BAP EIA Model 8012 because standard bottles may have low volume or leak.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Kroger Specialty Pharmacy is recalling MVW Complete Softgels and Chew Vitamins due to a lack of processing controls.
Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Kroger Specialty Pharmacy is recalling Vosevi 400/100/100 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.
Kroger Specialty Pharmacy is recalling Dexamethasone 4 mg tablets due to a lack of processing controls. The affected products were dispensed in five states.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Kitabis Pak 300 mg/5 mL Soln due to a lack of processing controls. The product was distributed in five states.
Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.
Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.
Kroger Specialty Pharmacy is recalling Revlimid 10 mg oral capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Randox Laboratories is recalling Lipase Assay kits due to potential contamination risks on Rx instruments. The recall affects specific lots distributed in West Virginia and Puerto Rico.
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