Medical DeviceMay 2, 2018
Diagnostic Hybrids MicroVue CIC-C1q EIA, Model A001 recall — FDA Z-1497-2018
A component of the kit was found to contain bacterial contamination.
Class IIIFDA: TerminatedDiagnostic Hybrids, Inc.
May 2018 recalls — page 24
These records include useful source details for the selected month.
Medical DeviceMay 2, 2018
Becton Dickinson & Company BD Vacutainer Push Button Blood Collection Set 0.6 x 19 mm x 305 recall — FDA Z-1531-2018
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceMay 2, 2018
CooperVision 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable recall — FDA Z-1518-2018
The secondary packaging is labeled with an incorrect expiration date.
Class IIIFDA: TerminatedCooperVision Inc.
Medical DeviceMay 2, 2018
CooperVision clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel recall — FDA Z-1515-2018
The secondary packaging is labeled with an incorrect expiration date.
Class IIIFDA: TerminatedCooperVision Inc.
Medical DeviceMay 2, 2018
CooperVision 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable recall — FDA Z-1517-2018
The secondary packaging is labeled with an incorrect expiration date.
Class IIIFDA: TerminatedCooperVision Inc.
Medical DeviceMay 2, 2018
Zimmer Biomet Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar recall — FDA Z-1522-2018
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 2, 2018
Life Technologies Oncomine Dx Target Test recall — FDA Z-1480-2018
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be…
Class IIFDA: TerminatedLife Technologies Corporation
Medical DeviceMay 2, 2018
Howmedica Osteonics Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The recall — FDA Z-1462-2018
Customers may receive the incorrect size implant from what is labeled on the box.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceMay 2, 2018
Covidien EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product recall — FDA Z-1528-2018
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceMay 2, 2018
Diagnostic Hybrids MicroVue SC5b-9 Plus EIA (RUO), Model A020 recall — FDA Z-1498-2018
A component of the kit was found to contain bacterial contamination.
Class IIIFDA: TerminatedDiagnostic Hybrids, Inc.
Medical DeviceMay 2, 2018
Becton Dickinson & Company BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 recall — FDA Z-1532-2018
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceMay 2, 2018
Covidien EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product recall — FDA Z-1527-2018
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceMay 2, 2018
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures recall — FDA Z-1536-2018
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceMay 2, 2018
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra recall — FDA Z-1519-2018
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement…
Class IIFDA: TerminatedRoche Diagnostics Corporation
Medical DeviceMay 2, 2018
Sofradim Production Versatex Monofilament Mesh 50 x 50cm, Product No recall — FDA Z-1523-2018
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware…
Class IIFDA: TerminatedSofradim Production
Medical DeviceMay 2, 2018
Stryker GmbH Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of recall — FDA Z-1526-2018
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Class IIFDA: TerminatedStryker GmbH
Medical DeviceMay 2, 2018
Integra LifeSciences The humeral stems trials are packaged in a kit for Titan Modular recall — FDA Z-1463-2018
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceMay 2, 2018
Diagnostic Hybrids MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029 recall — FDA Z-1499-2018
A component of the kit was found to contain bacterial contamination.
Class IIIFDA: TerminatedDiagnostic Hybrids, Inc.
Medical DeviceMay 2, 2018
Synthes Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally recall — FDA Z-1511-2018
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Class IIFDA: TerminatedSynthes, Inc.
Medical DeviceMay 2, 2018
Keystone Dental Genesis Surgical Cassette Tapered Implants are intended for placement recall — FDA Z-1485-2018
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Class IIFDA: TerminatedKeystone Dental Inc.
Medical DeviceMay 2, 2018
Ace Surgical Supply Co Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used recall — FDA Z-1464-2018
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Class IIFDA: TerminatedAce Surgical Supply Co., Inc.
Medical DeviceMay 2, 2018
Cook Advance 35LP Low-Profile PTA Balloon Dilatation Catheter recall — FDA Z-1521-2018
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMay 2, 2018
Accelerate PhenoTest BC kit, Ref #10101018 recall — FDA Z-1529-2018
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Class IIFDA: TerminatedAccelerate Diagnostics Inc.
Medical DeviceMay 2, 2018
Zimmer GmbH Avenir Muller Stem recall — FDA Z-1524-2018
A potential commingle that could result in the product in the package not matching the product on the outer label.
Class IIFDA: TerminatedZimmer GmbH
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.