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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- 2019-08-28FDA-DeviceArcos, IncClass IIBrand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
Battery packs may heat up abnormally and ignite in rare instance.
- 2019-08-28FDA-DeviceTiSport, LlcClass IITiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
- 2019-08-28FDA-DeviceDeRoyal Industries IncClass IIDeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
- 2019-08-28FDA-DeviceLuminex CorporationClass IILuminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
- 2019-08-28FDA-DeviceCincinnati Sub-Zero Products LLC, a Gentherm CompanyClass IIIMICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
- 2019-08-28FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
- 2019-08-28FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
- 2019-08-28FDA-DeviceEdwards Lifesciences, LLCClass IEdwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
- 2019-08-28FDA-DeviceEdwards Lifesciences, LLCClass IEdwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
- 2019-08-28FDA-DeviceEdwards Lifesciences, LLCClass IEdwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
- 2019-08-28FDA-DeviceEdwards Lifesciences, LLCClass IEdwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceLuminex CorporationClass IIAries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- 2019-08-21FDA-DeviceCanadian Hospital SpecialtiesClass IIMED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
The firm received a complaint that the connector detached from the feeding tube.
- 2019-08-21FDA-DeviceCodman & Shurtleff IncClass IIGALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Incorrect coil length on the label
- 2019-08-21FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)
- 2019-08-21FDA-DevicePega Medical Inc.Class IISLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
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