Medical DeviceJun 27, 2018
Paragon 28 P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy recall — FDA Z-2261-2018
Missing drill guide as stated in the package.
Class IIFDA: TerminatedParagon 28, Inc.
Recall records from June 2018
These records include useful source details for the selected month.
Medical DeviceJun 27, 2018
Synthes (USA) Products Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated recall — FDA Z-2245-2018
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceJun 27, 2018
Cyberonics VNS Therapy Programmer, Model 3000, v1.0 System recall — FDA Z-2255-2018
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations…
Class IIFDA: TerminatedCyberonics, Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet G-PIN 2.8BL 3.2PL 60CM 2PK recall — FDA Z-2236-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Siemens Medical Solutions USA Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material recall — FDA Z-2248-2018
Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet 3.2MM X 510MM COCR THD TIP recall — FDA Z-2240-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Draeger Medical Apollo Anesthesia Machine recall — FDA Z-2253-2018
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 27, 2018
Becton Dickinson & Company The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is recall — FDA Z-2259-2018
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceJun 27, 2018
Zimmer Biomet BALL TIP GUIDE WIRE 2.0MMX60CM recall — FDA Z-2235-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet BALL TIP GUIDE WIRE 3.2MMX98CM recall — FDA Z-2232-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Smith & Nephew Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) recall — FDA Z-2267-2018
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceJun 27, 2018
PENTAX of C2 CryoBalloon Focal Catheter, REF FG-1009 recall — FDA Z-2256-2018
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached…
Class IIFDA: TerminatedPENTAX of America Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for recall — FDA Z-2230-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet BEAD TIP GD WIRE 3.0MM X 60CM recall — FDA Z-2239-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Synthes (USA) Products Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set recall — FDA Z-2247-2018
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceJun 27, 2018
Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix recall — FDA Z-2257-2018
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Class IIIFDA: TerminatedQuantimetrix Corporation
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08 recall — FDA Z-2265-2018
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
Draeger Medical Fabius GS MRI Anesthesia Machine recall — FDA Z-2252-2018
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 27, 2018
Zimmer Biomet DRILL PT GUIDE WIRE 2MM X 60CM recall — FDA Z-2231-2018
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 27, 2018
Draeger Medical Fabius GS Premium Anesthesia Machine recall — FDA Z-2250-2018
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17 recall — FDA Z-2262-2018
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
Draeger Medical Fabius GS Tiro Anesthesia Machine recall — FDA Z-2251-2018
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 27, 2018
Draeger Medical Perseus A500 Anesthesia Machine recall — FDA Z-2254-2018
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 27, 2018
Becton Dickinson & Company The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is recall — FDA Z-2258-2018
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
Class IIFDA: TerminatedBecton Dickinson & Company
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.