March 27, 2024Medical DevicesFDA
Landauer recalls microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as
Hazard: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the va
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire int
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the v
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va
Hazard: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
March 27, 2024Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Hazard: When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
March 27, 2024Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Hazard: When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
March 27, 2024Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Hazard: When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
March 27, 2024Medical DevicesFDA
Covidien recalls Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Hazard: Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
March 27, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
March 27, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that
Hazard: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
March 27, 2024Medical DevicesFDA
Thommen Medical AG recalls impression coping, repositionable, short, screw-retained, PF 4.0
Hazard: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
March 27, 2024Medical DevicesFDA
Preat Corp recalls Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Hazard: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
March 27, 2024Medical DevicesFDA
In2Bones, SAS recalls I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Hazard: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
March 27, 2024Medical DevicesFDA
In2Bones, SAS recalls I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Hazard: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
March 27, 2024Medical DevicesFDA
Think Surgical, Inc. recalls Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S
Hazard: There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
March 27, 2024Medical DevicesFDA
Medtronic Inc. recalls Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Hazard: There is a potential for sterile package breach.
March 27, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Hazard: Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
March 27, 2024Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Hazard: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.