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FDA public records

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 934

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

Medical DeviceJun 28, 2017

Medtronic MiniMed 670G Insulin Infusion Pump, Catalog No recall — FDA Z-2605-2017

Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceJun 28, 2017

Medtronic MiniMed 620G Insulin Infusion Pump, Catalog No recall — FDA Z-2602-2017

Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceJun 28, 2017

Medtronic MiniMed 630G Insulin Infusion Pump, Catalog No recall — FDA Z-2603-2017

Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceJun 28, 2017

DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The recall — FDA Z-2615-2017

Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

Class IIFDA: TerminatedDePuy Mitek, Inc., a Johnson & Johnson Co.

Medical DeviceJun 28, 2017

Ion Beam Applications S.A Proteus 235 recall — FDA Z-2592-2017

It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS)…

Class IIFDA: TerminatedIon Beam Applications S.A.

Medical DeviceJun 28, 2017

Vascular Solutions Venture RX Catheter, Model 5820 recall — FDA Z-2224-2017

Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model…

Class IFDA: TerminatedVascular Solutions, Inc.

Medical DeviceJun 28, 2017

Siemens Healthcare Diagnostics Dimension Vista Prolactin (PRL) Flex reagent cartridge recall — FDA Z-2610-2017

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJun 28, 2017

DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage recall — FDA Z-2617-2017

Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

Class IIFDA: TerminatedDePuy Mitek, Inc., a Johnson & Johnson Co.

Medical DeviceJun 28, 2017

Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device recall — FDA Z-2621-2017

Elevating Monitor Suspension column dropping and will not rise back up.

Class IIFDA: TerminatedOmega Medical Imaging, Inc.

Medical DeviceJun 28, 2017

Medtronic MiniMed 640G Insulin Infusion Pump, Catalog No recall — FDA Z-2604-2017

Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceJun 28, 2017

Merge OrthoPACS software recall — FDA Z-2601-2017

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceJun 28, 2017

Siemens Healthcare Diagnostics Dimension Vista Digoxin (DIGXN) Flex reagent cartridge recall — FDA Z-2607-2017

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJun 28, 2017

Siemens Healthcare Diagnostics Dimension Vista Estradiol (E2) Flex reagent cartridge recall — FDA Z-2608-2017

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJun 28, 2017

Siemens Healthcare Diagnostics Dimension Vista Ferritin (FERR) Flex reagent cartridge recall — FDA Z-2609-2017

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJun 28, 2017

Siemens Healthcare Diagnostics Dimension Troponin 1 (TNI) Flex reagent cartridge recall — FDA Z-2606-2017

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJun 21, 2017

Zimmer Biomet FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL recall — FDA Z-2598-2017

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceJun 21, 2017

Biomerieux VITEK 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards recall — FDA Z-2513-2017

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceJun 21, 2017

Pentax of Video Cytoscopes recall — FDA Z-2325-2017

This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these…

Class IIFDA: TerminatedPentax of America Inc.

Medical DeviceJun 21, 2017

Biomerieux VITEK 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards recall — FDA Z-2508-2017

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceJun 21, 2017

Medtronic SCHRITTMACHER ANGIO X3 recall — FDA Z-2548-2017

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Class IIFDA: TerminatedMedtronic

Medical DeviceJun 21, 2017

Biomerieux VITEK 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per recall — FDA Z-2355-2017

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceJun 21, 2017

Biomerieux VITEK 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per recall — FDA Z-2428-2017

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceJun 21, 2017

Biomerieux VITEK 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per recall — FDA Z-2441-2017

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceJun 21, 2017

Zimmer Biomet Por fullct fem st 17x200mm, Sterile recall — FDA Z-2579-2017

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Class IIFDA: TerminatedZimmer Biomet, 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.