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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

25,099medical device recall records

2,245FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.758 records

Database records

Records — page 561

25,099 detailed records are currently available in this category.

Medical DeviceOct 28, 2020

GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0128-2021

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Class IIFDA: TerminatedGE Healthcare, LLC

Medical DeviceOct 28, 2020

ICU Medical PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD recall — FDA Z-0273-2021

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 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit recall — FDA Z-0231-2021

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 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product recall — FDA Z-0167-2021

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 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock recall — FDA Z-0215-2021

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 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way recall — FDA Z-0219-2021

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 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave recall — FDA Z-0198-2021

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-0112-2021

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

Class IFDA: TerminatedVascular Solutions, Inc.

Medical DeviceOct 28, 2020

Smith & Nephew HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product recall — FDA Z-0173-2021

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 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp recall — FDA Z-0276-2021

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 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product recall — FDA Z-0174-2021

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 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV recall — FDA Z-0229-2021

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

Boston Scientific Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm recall — FDA Z-0181-2021

Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is…

Class IIFDA: TerminatedBoston Scientific Corporation

Medical DeviceOct 28, 2020

ICU Medical 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave recall — FDA Z-0222-2021

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 SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case recall — FDA Z-0280-2021

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 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product recall — FDA Z-0162-2021

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 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave recall — FDA Z-0260-2021

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 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 recall — FDA Z-0255-2021

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

Siemens Healthcare Diagnostics Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No recall — FDA Z-0115-2021

Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 28, 2020

ICU Medical 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave recall — FDA Z-0228-2021

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 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock recall — FDA Z-0216-2021

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 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear recall — FDA Z-0259-2021

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 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 recall — FDA Z-0240-2021

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

GE Healthcare Tomographic Imager Combining Emission Computed Tomography With Nuclear recall — FDA Z-0131-2021

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Class IIFDA: TerminatedGE Healthcare, LLC

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.