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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.

28,065medical device recall records

2,353FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 958

28,065 detailed records are currently available in this category.

Medical DeviceMay 10, 2017

Breg Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as recall — FDA Z-1905-2017

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Class IIFDA: TerminatedBreg Inc.

Medical DeviceMay 10, 2017

Merge Healthcare Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number recall — FDA Z-1923-2017

The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small…

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceMay 10, 2017

Breg Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as recall — FDA Z-1903-2017

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Class IIFDA: TerminatedBreg Inc.

Medical DeviceMay 10, 2017

The Anspach Effort Electronic Foot Control with Direction Switch Product Usage: Electric recall — FDA Z-1948-2017

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Roche Diabetes Care Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and recall — FDA Z-1899-2017

A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.

Class IIFDA: TerminatedRoche Diabetes Care, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R recall — FDA Z-1917-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

The Anspach Effort Electronic Foot Control with Direction or Irrigation Switches Product recall — FDA Z-1949-2017

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Beckman Coulter AQUIOS CL Flow Cytometer, Ref no recall — FDA Z-2035-2017

Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceMay 10, 2017

Zimmer Trabecular Metal Technology The TM Ardis Interbody System implant is a convex recall — FDA Z-1892-2017

This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was…

Class IIIFDA: TerminatedZimmer Trabecular Metal Technology, Inc.

Medical DeviceMay 10, 2017

The Anspach Effort AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system recall — FDA Z-1932-2017

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R recall — FDA Z-1914-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R recall — FDA Z-1918-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R recall — FDA Z-1915-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R recall — FDA Z-1916-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Breg If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile recall — FDA Z-1908-2017

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Class IIFDA: TerminatedBreg Inc.

Medical DeviceMay 10, 2017

Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock recall — FDA Z-1928-2017

ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

Class IIFDA: TerminatedDale Medical Products, Inc.

Medical DeviceMay 10, 2017

Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 recall — FDA Z-1874-2017

Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without…

Class IFDA: TerminatedNewport Medical Instruments Inc.

Medical DeviceMay 10, 2017

Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg. recall — FDA Z-1929-2017

A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

Class IIFDA: TerminatedOlympus Corporation of the Americas

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY recall — FDA Z-1910-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE recall — FDA Z-1920-2017

The stability data does not support the product labeled with a 10-year shelf life.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

The Anspach Effort 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system recall — FDA Z-1987-2017

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Medtronic MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below recall — FDA Z-1890-2017

Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceMay 10, 2017

Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock recall — FDA Z-1927-2017

ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

Class IIFDA: TerminatedDale Medical Products, Inc.

Medical DeviceMay 10, 2017

The Anspach Effort AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system recall — FDA Z-1931-2017

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

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.