Medical DeviceJun 12, 2019
Microbiologics Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI recall — FDA Z-1731-2019
Product with incorrect shelf life.
Class IIFDA: OngoingMicrobiologics Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 129
Records are ordered by the best available source date.
Medical DeviceJun 12, 2019
Bio-Rad Laboratories MRSASelect II, IVD, REF 63758 (20 plates per package) recall — FDA Z-1743-2019
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class IIFDA: TerminatedBio-Rad Laboratories, Inc.
Medical DeviceJun 12, 2019
Zimmer Biomet Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT recall — FDA Z-1735-2019
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 12, 2019
Smiths Medical ASD Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety recall — FDA Z-1733-2019
Incorrect needle length and gage.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceJun 12, 2019
OriGen Biomedical ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F recall — FDA Z-1230-2019
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
Class IFDA: TerminatedOriGen Biomedical, Inc.
Medical DeviceJun 12, 2019
Microline Surgical TLS2 Thermal Ligating Shears, Catalog Number 132-131D recall — FDA Z-1698-2019
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
Class IIFDA: TerminatedMicroline Surgical, Inc.
Medical DeviceJun 12, 2019
Flowonix Medical Prometra Programmable Pump, Cat recall — FDA Z-1714-2019
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect…
Class IIFDA: TerminatedFlowonix Medical Inc.
Medical DeviceJun 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator recall — FDA Z-1701-2019
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceJun 12, 2019
Maquet Cardiovascular Us Sales GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) recall — FDA Z-1734-2019
User may suffer an electric shock when coming in contact with the exposed electronic components
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJun 12, 2019
Zimmer Biomet Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item recall — FDA Z-1738-2019
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 12, 2019
I.T.S. GmbH Rim Plate, 10-Hole, Left, PRS RX System recall — FDA Z-1718-2019
The titanium implant has the wrong article number laser marked on it.
Class IIFDA: OngoingI.T.S. GmbH
Medical DeviceJun 12, 2019
Microbiologics Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 recall — FDA Z-1730-2019
Product with incorrect shelf life.
Class IIFDA: OngoingMicrobiologics Inc.
Medical DeviceJun 12, 2019
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is recall — FDA Z-1707-2019
Certain lots were mislabeled with incorrect product number.
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceJun 12, 2019
Kerr/Pentron, DBA Kerr Corporation and Pentron Regimen 28 Day - Glutaraldehyde Sterilizing recall — FDA Z-1721-2019
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Class IIFDA: TerminatedKerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Medical DeviceJun 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG recall — FDA Z-1704-2019
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceJun 12, 2019
Smiths Medical ASD Portex Blue Line Ultra Tracheostomy Tube Inner Cannula recall — FDA Z-1732-2019
Packaged with an incorrect size inner cannula.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceJun 12, 2019
Cook Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 recall — FDA Z-1723-2019
Affected products may have been manufactured with the catheter distal end hole too small
Class IIFDA: TerminatedCook Inc.
Medical DeviceJun 12, 2019
Cook Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 recall — FDA Z-1722-2019
Affected products may have been manufactured with the catheter distal end hole too small
Class IIFDA: TerminatedCook Inc.
Medical DeviceJun 12, 2019
Bio-Rad Laboratories MRSASelect, IVD, REF 63747, containing 20 plates per package recall — FDA Z-1742-2019
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class IIFDA: TerminatedBio-Rad Laboratories, Inc.
Medical DeviceJun 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG recall — FDA Z-1702-2019
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceJun 12, 2019
OriGen Biomedical ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F recall — FDA Z-1231-2019
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
Class IFDA: TerminatedOriGen Biomedical, Inc.
Medical DeviceJun 12, 2019
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an recall — FDA Z-1727-2019
The heated tube sets were consistently leaking and detaching from the cassette.
Class IIFDA: TerminatedStryker Corporation
Medical DeviceJun 12, 2019
Zimmer Biomet Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item recall — FDA Z-1740-2019
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 12, 2019
OMNIlife science OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics recall — FDA Z-1717-2019
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Class IIFDA: TerminatedOMNIlife science Inc.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.