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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 1096

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

Medical DeviceMar 30, 2016

Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # recall — FDA Z-1195-2016

Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

Class IIFDA: TerminatedArthrex, Inc.

Medical DeviceMar 30, 2016

QiG Group Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 recall — FDA Z-1192-2016

The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5…

Class IIFDA: TerminatedQiG Group LLC

Medical DeviceMar 30, 2016

Siemens Healthcare Diagnostics IMMULITE 1000 Estradiol Test Code E2 recall — FDA Z-1242-2016

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

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMar 30, 2016

Siemens Healthcare Diagnostics Dimension Vista LOCI Estradiol Test Code E2 recall — FDA Z-1241-2016

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

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMar 30, 2016

QiG Group Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 recall — FDA Z-1194-2016

The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5…

Class IIFDA: TerminatedQiG Group LLC

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are recall — FDA Z-1216-2016

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 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are recall — FDA Z-1197-2016

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

Medtronic Navigation BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged recall — FDA Z-1234-2016

Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

Class IIFDA: TerminatedMedtronic Navigation, Inc.

Medical DeviceMar 30, 2016

Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes recall — FDA Z-1217-2016

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 SIL FLY Item Code: P4P16SD Castile soap towelettes are recall — FDA Z-1209-2016

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

CareFusion 303 Alaris PC Unit, Infusion Pump Model 8000, Part No recall — FDA Z-1239-2016

CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

Class IIFDA: TerminatedCareFusion 303, Inc.

Medical DeviceMar 30, 2016

Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used recall — FDA Z-1202-2016

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

Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with recall — FDA Z-1175-2016

When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceMar 30, 2016

Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap recall — FDA Z-1222-2016

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

Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip recall — FDA Z-1247-2016

Straight needle labeled as a curved needle

Class IIFDA: TerminatedNeurotherm, Inc.

Medical DeviceMar 30, 2016

Cook Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation recall — FDA Z-1238-2016

Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook…

Class IIFDA: TerminatedCook Inc.

Medical DeviceMar 30, 2016

Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP recall — FDA Z-1218-2016

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 KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used recall — FDA Z-1203-2016

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 PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used recall — FDA Z-1227-2016

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 PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are recall — FDA Z-1224-2016

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 PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are recall — FDA Z-1204-2016

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 PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are recall — FDA Z-1206-2016

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 UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes recall — FDA Z-1213-2016

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

Cook UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a recall — FDA Z-1237-2016

Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook…

Class IIFDA: TerminatedCook 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.