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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 957

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

Medical DeviceMay 17, 2017

AMO Healon V, Part No. 10290045 recall — FDA Z-2067-2017

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceMay 17, 2017

CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of recall — FDA Z-2054-2017

The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the…

Class IIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceMay 10, 2017

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID recall — FDA Z-1921-2017

When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an…

Class IIFDA: TerminatedRoho Inc.

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY recall — FDA Z-1911-2017

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

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Sysmex recall — FDA Z-2034-2017

Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents.…

Class IIFDA: TerminatedSysmex America Inc.

Medical DeviceMay 10, 2017

Becton Dickinson & Company BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic recall — FDA Z-1897-2017

Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

Class IIFDA: TerminatedBecton Dickinson & Company

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R recall — FDA Z-1913-2017

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 Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used recall — FDA Z-1906-2017

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

Richard-Allan Scientific Company Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 recall — FDA Z-1895-2017

Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

Class IIFDA: TerminatedRichard-Allan Scientific Company

Medical DeviceMay 10, 2017

The Anspach Effort System Console, Single Port, with irrigation Product Usage: Electric recall — FDA Z-1956-2017

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

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Bard Peripheral Vascular MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201 recall — FDA Z-1900-2017

It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.

Class IIFDA: TerminatedBard Peripheral Vascular Inc.

Medical DeviceMay 10, 2017

Breg Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as recall — FDA Z-1902-2017

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

Natus Medical Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 recall — FDA Z-1924-2017

The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board…

Class IIFDA: TerminatedNatus Medical Inc.

Medical DeviceMay 10, 2017

The Anspach Effort Electronic Foot Control with Direction or Irrigation Switches Product recall — FDA Z-1946-2017

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

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceMay 10, 2017

Breg Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used recall — FDA Z-1904-2017

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

Terumo Medical Destination Renal Guiding Sheath Intended for the introduction of recall — FDA Z-2033-2017

Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination products may not contain the labeled 5 cm of coating. While there have…

Class IIFDA: TerminatedTerumo Medical Corporation

Medical DeviceMay 10, 2017

Breg Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an recall — FDA Z-1907-2017

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

Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V recall — FDA Z-1894-2017

The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

Class IIFDA: TerminatedSonesta Medical Ab

Medical DeviceMay 10, 2017

Terumo Medical SurFlo IV Catheter recall — FDA Z-1896-2017

According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A…

Class IIFDA: TerminatedTerumo Medical Corporation

Medical DeviceMay 10, 2017

Breg Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used recall — FDA Z-1901-2017

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 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic recall — FDA Z-2001-2017

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, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY recall — FDA Z-1912-2017

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

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMay 10, 2017

Boston Scientific The JETSTREAM is a rotational atherectomy catheter system designed for use recall — FDA Z-1922-2017

Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some…

Class IIFDA: TerminatedBoston Scientific Corporation

Medical DeviceMay 10, 2017

Smith & Nephew RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY recall — FDA Z-1909-2017

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

Class IIFDA: TerminatedSmith & Nephew, 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.