DrugDec 6, 2017
Levetiracetam Oral Solution, USP, 100 mg/mL recall — FDA D-0099-2018
Presence of foreign substance (screw)
Class IIFDA: TerminatedHetero Labs, Ltd. - Unit III
Latest records
Latest recalls — page 1539
The newest recall records with useful source details are listed here.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile recall — FDA Z-0136-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 recall — FDA Z-0124-2018
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to…
Class IIFDA: TerminatedHalyard Health, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24 recall — FDA Z-0134-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile recall — FDA Z-0126-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Zimmer Biomet ROSA Surgical Device 2.5.8 recall — FDA Z-0115-2018
Potential for software to change the final tool orientation for the command position without command.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 29, 2017
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials recall — FDA Z-0118-2018
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to…
Class IIFDA: TerminatedHalyard Health, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile recall — FDA Z-0144-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14 recall — FDA Z-0130-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Abbott Laboratories Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical recall — FDA Z-0166-2018
The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Class IIFDA: CompletedAbbott Laboratories, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX recall — FDA Z-0152-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23 recall — FDA Z-0133-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile recall — FDA Z-0137-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Zimmer Biomet ROSA Brain 3.0 Intended for the spatial positioning and orientation of recall — FDA Z-0105-2018
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 29, 2017
Medline Industries Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 recall — FDA Z-0163-2018
The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceNov 29, 2017
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials recall — FDA Z-0123-2018
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to…
Class IIFDA: TerminatedHalyard Health, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX recall — FDA Z-0148-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX recall — FDA Z-0147-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Spacelabs Healthcare Arkon Anesthesia Delivery System, Model 99999, and software version recall — FDA Z-0072-2018
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that…
Class IFDA: TerminatedSpacelabs Healthcare, Ltd.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12 recall — FDA Z-0128-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX recall — FDA Z-0155-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11 recall — FDA Z-0127-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile recall — FDA Z-0139-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 29, 2017
Exactech Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX recall — FDA Z-0157-2018
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Class IIFDA: TerminatedExactech, Inc.
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