Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 950

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

Medical DeviceOct 28, 2020

Stryker Neurovascular Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM) recall — FDA Z-0114-2021

Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the…

Class IFDA: TerminatedStryker Neurovascular

Medical DeviceOct 28, 2020

Medtronic Vascular Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 recall — FDA Z-0087-2021

Subsequent failure of catheters in the field and failed quality testing

Class IFDA: TerminatedMedtronic Vascular

Medical DeviceOct 28, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) recall — FDA Z-0122-2021

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Class IFDA: TerminatedBaxter Healthcare Corporation

Medical DeviceOct 28, 2020

ICU Medical 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 recall — FDA Z-0278-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0111-2021

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Class IFDA: TerminatedVascular Solutions, Inc.

Medical DeviceOct 28, 2020

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with recall — FDA Z-0281-2021

Due to non-surgical isolation gowns not meeting all performance test requirements.

Class IIFDA: TerminatedSobel Westex

Medical DeviceOct 28, 2020

Smith & Nephew TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product recall — FDA Z-0159-2021

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceOct 28, 2020

ICU Medical 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve recall — FDA Z-0238-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

Smith & Nephew TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product recall — FDA Z-0163-2021

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceOct 28, 2020

Smith & Nephew ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product recall — FDA Z-0145-2021

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceOct 28, 2020

Smith & Nephew OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product recall — FDA Z-0149-2021

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceOct 28, 2020

Smith & Nephew TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number recall — FDA Z-0138-2021

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceOct 28, 2020

ICU Medical NanoClave Stopcock w/NanoClave recall — FDA Z-0212-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD recall — FDA Z-0243-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per recall — FDA Z-0237-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case recall — FDA Z-0261-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 recall — FDA Z-0190-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active recall — FDA Z-0178-2021

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Class IIFDA: OngoingBien-Air Surgery Sa

Medical DeviceOct 28, 2020

ICU Medical 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear recall — FDA Z-0189-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks recall — FDA Z-0214-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear recall — FDA Z-0196-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit recall — FDA Z-0253-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 recall — FDA Z-0274-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 28, 2020

ICU Medical 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 recall — FDA Z-0275-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

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