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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.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1095

28,992 detailed records are currently available in this category.

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are recall — FDA Z-1212-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are recall — FDA Z-1228-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap recall — FDA Z-1214-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Siemens Healthcare Diagnostics IMMULITE 2000 EstradiolTest Code E2 recall — FDA Z-1243-2016

The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMar 30, 2016

Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes recall — FDA Z-1219-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are recall — FDA Z-1211-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 recall — FDA Z-1240-2016

The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMar 30, 2016

AcuFocus KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling recall — FDA Z-1235-2016

AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.

Class IIFDA: TerminatedAcuFocus, Inc.

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap recall — FDA Z-1207-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Ambu recall — FDA Z-1236-2016

Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile…

Class IIFDA: TerminatedAmbu Inc.

Medical DeviceMar 30, 2016

Roche Diagnostics Operations cobas p 512 pre-analytical system Pre-analytical sample recall — FDA Z-1233-2016

Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process.…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceMar 30, 2016

Siemens Medical Solutions USA syngo X Workplace is a medical workstation for real-time recall — FDA Z-1232-2016

After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 30, 2016

Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used recall — FDA Z-1223-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MHI-TM2000 Linear Accelerator System recall — FDA Z-1244-2016

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under…

Class IIFDA: TerminatedMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY…

Medical DeviceMar 30, 2016

Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap recall — FDA Z-1226-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are recall — FDA Z-1225-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes recall — FDA Z-1215-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used recall — FDA Z-1198-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are recall — FDA Z-1199-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes recall — FDA Z-1208-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Intuitive Surgical da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console recall — FDA Z-1191-2016

da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceMar 30, 2016

Zimmer Spine Universal Clamp System recall — FDA Z-1189-2016

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and…

Class IIFDA: TerminatedZimmer Spine, Inc.

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes recall — FDA Z-1210-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes recall — FDA Z-1221-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien 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.