Medical DeviceFeb 21, 2018
AMEDA Purely Yours Breast Pump recall — FDA Z-0616-2018
Two specific lots was incorrectly manufactured containing a UK power adapter.
Class IIIFDA: OngoingAMEDA, Inc.
Latest records
Latest recalls — page 1499
The newest recall records with useful source details are listed here.
Medical DeviceFeb 21, 2018
B. Braun Medical Perifix Single Dose Epidural Anesthesia Tray recall — FDA Z-0568-2018
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceFeb 21, 2018
Philips Medical Systems (Cleveland) Ingenuity TF PET/CT (model 882442) running software recall — FDA Z-0562-2018
A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceFeb 21, 2018
Zimmer Surgical A.T.S. 2200TS Tourniquet Systems, Personalized Pressure recall — FDA Z-0613-2018
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Class IIFDA: TerminatedZimmer Surgical Inc.
Medical DeviceFeb 21, 2018
3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Sterile Full Access recall — FDA Z-0599-2018
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting…
Class IIFDA: Terminated3M Company - Health Care Business
Medical DeviceFeb 21, 2018
B. Braun Medical PENCAN Spinal Anesthesia Tray recall — FDA Z-0572-2018
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceFeb 21, 2018
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther recall — FDA Z-0595-2018
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceFeb 21, 2018
Kalila Medical Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded recall — FDA Z-0564-2018
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
Class IIFDA: TerminatedKalila Medical
Medical DeviceFeb 21, 2018
Beckman Coulter Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter recall — FDA Z-0605-2018
Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceFeb 21, 2018
3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Full Access recall — FDA Z-0598-2018
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting…
Class IIFDA: Terminated3M Company - Health Care Business
Medical DeviceFeb 21, 2018
Roche Diabetes Care Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / recall — FDA Z-0625-2018
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of…
Class IIFDA: TerminatedRoche Diabetes Care, Inc.
Medical DeviceFeb 21, 2018
Zimmer Biomet Persona Partial Knee System Product Usage: The Persona Partial Knee System recall — FDA Z-0596-2018
Potential for the Persona Partial Knee Impactor Pad to fracture.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 21, 2018
AVID Medical QA Pack AV10654-10 recall — FDA Z-0581-2018
The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceFeb 21, 2018
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS recall — FDA Z-0601-2018
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 21, 2018
B. Braun Medical Perifix Epidural AnesthesiaTray recall — FDA Z-0570-2018
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceFeb 21, 2018
DePuy Orthopaedics CORAIL HIGH OFFSET STEM Collarless SIZE 14 recall — FDA Z-0594-2018
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceFeb 21, 2018
Cook Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog recall — FDA Z-0632-2018
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Class IIFDA: TerminatedCook Inc.
Medical DeviceFeb 21, 2018
Synthes USA Norian Drillable Inject recall — FDA Z-0618-2018
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit…
Class IIFDA: TerminatedSynthes USA
Medical DeviceFeb 21, 2018
Keystone Dental Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog recall — FDA Z-0608-2018
Abutments are unable to accept the final abutment screw
Class IIFDA: TerminatedKeystone Dental Inc.
Medical DeviceFeb 21, 2018
Aesculap Implant Systems The ELAN 4 Air System is intended for high speed cutting, sawing recall — FDA Z-0623-2018
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceFeb 21, 2018
Zimmer Biomet AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802 recall — FDA Z-0627-2018
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 21, 2018
B. Braun Medical Perifix Continuous Epidural Anesthesia Tray recall — FDA Z-0567-2018
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceFeb 21, 2018
B. Braun Medical Spinal & Epidural Anesthesia Tray recall — FDA Z-0573-2018
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceFeb 21, 2018
Aesculap Implant Systems ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN recall — FDA Z-0619-2018
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Class IIFDA: TerminatedAesculap Implant Systems LLC
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