Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceOrthoPediatrics CorpClass IIOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
- 2019-10-23FDA-DeviceIntegra LifeSciences Corp.Class IICerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
- 2019-10-23FDA-DeviceMedtronic Vascular Galway DBA Medtronic IrelandClass IISolarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SL
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
- 2019-10-23FDA-DeviceMedtronic Vascular Galway DBA Medtronic IrelandClass IIEuphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICenturion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICenturion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
- 2019-10-16FDA-DeviceHoriba Instruments IncorporatedClass IIClinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
- 2019-10-16FDA-DeviceTriMed Inc.Class IITriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
- 2019-10-16FDA-DeviceGE Healthcare, LLCClass IIAchilles Express Bone Sonometer
Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
- 2019-10-16FDA-DeviceGE Healthcare, LLCClass IIAchilles Insight Bone Sonometer
Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
- 2019-10-16FDA-DeviceK2M, IncClass IIYUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028,
Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.
- 2019-10-16FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
- 2019-10-16FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIUVC TRAY UVT875
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IITRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIINVASIVE PROCEDURE TRAY MNS9510
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIIV KIT - SORBAVIEW IVS3475
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIIV SECUREMENT KIT IVS3405
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIIV START KIT IV8440
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIVANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IIOR VANTEX 7FR 3L 16CM CVC ECVC6665
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICENTRAL LINE BUNDLE ECVC6375
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICVC BUNDLE, 20CM, 3L, PI ECVC5120A
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
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