Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1153

The newest recall records with useful source details are listed here.

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for recall — FDA Z-2639-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070", REF SA6AL40. for recall — FDA Z-2678-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for recall — FDA Z-2697-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Helena Laboratories Cascade Abrazo aPTT Test Card, Model 5722, For Export Only recall — FDA Z-2761-2019

Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

Class IIFDA: TerminatedHelena Laboratories, Corp.

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. for recall — FDA Z-2672-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. recall — FDA Z-2586-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for recall — FDA Z-2650-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. recall — FDA Z-2607-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. recall — FDA Z-2708-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for recall — FDA Z-2665-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for recall — FDA Z-2706-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for recall — FDA Z-2677-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. recall — FDA Z-2578-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

ELITech Group B.V Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage recall — FDA Z-2764-2019

Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

Class IIIFDA: TerminatedELITech Group B.V.

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0 SH, .070", REF SA6AL10SH. for recall — FDA Z-2638-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for recall — FDA Z-2651-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for recall — FDA Z-2619-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Inter-Med Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF recall — FDA Z-0012-2020

The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to…

Class IIFDA: TerminatedInter-Med LLC

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. recall — FDA Z-2576-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. recall — FDA Z-2579-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. recall — FDA Z-2591-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for recall — FDA Z-2610-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. recall — FDA Z-2590-2019

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Class IFDA: CompletedMedtronic Vascular

Medical DeviceOct 9, 2019

Stryker Instruments Div. of Stryker C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI recall — FDA Z-0023-2020

Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing…

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

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