Browse Device Recalls

1,003 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,003 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,003 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 2XLARGE, Gown. Item Code 9578 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK XLARGE, Gown. Item Code 9548 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK LARGE, Gown. Item Code 9518 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Nov 4, 2019 Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... False positive results due to potential contamination of reagent. Class II Immuno-Mycologics, Inc
Aug 1, 2019 Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 ... The firm has become aware that the sensor cover, a component of the single-use navigation kit ma... Class II Imactis
Jun 3, 2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... Class II Roche Diagnostics Corporation
May 29, 2019 Liberty Cycler Cassettes (a disposable cassette that is intended to be used t... Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler... Class II Fresenius Medical Care Renal Therapies Group, LLC
May 20, 2019 Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P... Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... Class II Maquet Cardiovascular Us Sales, Llc
May 20, 2019 Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr... Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... Class II Maquet Cardiovascular Us Sales, Llc
Feb 28, 2019 SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... Class I Becton Dickinson & Company
Dec 12, 2018 Dimension Vista 500, Analyzer, chemistry Model no. 10284473 When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... Class II Siemens Healthcare Diagnostics, Inc.
Dec 12, 2018 Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... Class II Siemens Healthcare Diagnostics, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi... Potential compromise of product sterility due to breach of sterile barrier. Class II Medical Action Industries Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.