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.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- 2020-02-12FDA-DeviceCook Inc.Class IIUniversa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIUniversa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IISof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IISof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIKwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIC-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIBander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIUrethral Dilator Set, Global Product No. G14185
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIUrethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIPercutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIPercutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIPercutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIAngled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIAngled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIWire Guide, Guidewire, Global Product Number G14326
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIRoadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIPTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIHeavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIFixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceCook Inc.Class IIBentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IISafeline Y-Type Blood Set, Catalog Number V2500
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IISafeline Y-Type Blood Set, Catalog Number NF5140
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IIY-Type Blood Set, Catalog Number 490530
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IIY-Type Blood Set, Catalog Number 490425
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IIY-Type Blood Set, Catalog Number 490314
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IIY-Type Blood Set, Catalog Number 490293
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Potential for leakage at the joint between the blood filters and tubing
- 2020-02-12FDA-DeviceDatascope CorporationClass IIReinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
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