Medical DeviceJan 3, 2018
Sterilmed St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl recall — FDA Z-0213-2018
Inadequate seal due to lack of adhesive glue
Class IFDA: TerminatedSterilmed Inc.
Latest records
Latest recalls — page 1529
The newest recall records with useful source details are listed here.
Medical DeviceJan 3, 2018
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01 recall — FDA Z-0290-2018
The serum may fail to agglutinate within the specified minimum reaction time.
Class IIFDA: TerminatedRemel Inc.
Medical DeviceJan 3, 2018
Randox Laboratories Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD recall — FDA Z-0285-2018
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the…
Class IIFDA: TerminatedRandox Laboratories Ltd.
Medical DeviceJan 3, 2018
Accuray Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment recall — FDA Z-0286-2018
Uncontrolled couch Z-axis movement (descent)
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceJan 3, 2018
Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx recall — FDA Z-0273-2018
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU)…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceJan 3, 2018
Accuray TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment recall — FDA Z-0287-2018
Uncontrolled couch Z-axis movement (descent)
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceJan 3, 2018
L3 Security & Detection System Cabinet X-ray system used for security screening of checked recall — FDA Z-0270-2018
L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with the main x-ray scanner tunnel.…
Class IIFDA: TerminatedL3 Security & Detection
Medical DeviceJan 3, 2018
Accuray TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment recall — FDA Z-0288-2018
Uncontrolled couch Z-axis movement (descent)
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceJan 3, 2018
Accuray TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment recall — FDA Z-0289-2018
Uncontrolled couch Z-axis movement (descent)
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceJan 3, 2018
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use recall — FDA Z-0291-2018
The power drill torque limiter may break during use in surgery application.
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceJan 3, 2018
Medline Industries Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek recall — FDA Z-0295-2018
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceJan 3, 2018
Philips Electronics IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server recall — FDA Z-0292-2018
Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
Class IIFDA: OngoingPhilips Electronics North America Corporation
FoodJan 3, 2018
Lovejoy Bakers Rosemary Poppyseed crackers, net wt recall — FDA F-0517-2018
Rosemary Poppyseed crackers, net wt. 6 oz, are recalled due to undeclared wheat. Flour was declared but wheat was not declared in the Ingredients statement.
Class IIFDA: TerminatedLovejoy Bakers Inc.
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 recall — FDA D-0139-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
Pharmedium Services HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 recall — FDA D-0132-2018
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class IIIFDA: TerminatedPharmedium Services, LLC
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% recall — FDA D-0138-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles recall — FDA D-0133-2018
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with…
Class IIIFDA: TerminatedKeryx Biopharmaceuticals, Inc.
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Oxytocin 30 units in 0.9% Sodium Chloride 500 recall — FDA D-0143-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Phenylephrine 1000 mcg in 0.9% Sodium Chloride recall — FDA D-0144-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
Pharmedium Services morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 recall — FDA D-0130-2018
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class IIIFDA: TerminatedPharmedium Services, LLC
DrugJan 3, 2018
Pharmedium Services morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 recall — FDA D-0131-2018
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class IIIFDA: TerminatedPharmedium Services, LLC
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Succinylcholine chloride 100 mg in 5 mL syringe recall — FDA D-0145-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Neostigmine Methylsulfate 5 mg/5 mL, 5 mL recall — FDA D-0141-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJan 3, 2018
SSM Health Care St. Louis DBA SSM St. Clare Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 recall — FDA D-0136-2018
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually…
Class IIFDA: TerminatedSSM Health Care St. Louis DBA SSM St. Clare Health…
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026244 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026371 records · 4 categoriesJune 2026375 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories