Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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DateProductReasonClassFirm
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiov... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCel... Class II Roche Diagnostics Corporation
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiov... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERA... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 14, 2019 Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can ... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instrument... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Kit - Product Usage: The kit itself does not have a specifi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They ca... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: Th... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They c... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to b... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They c... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twis... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Tw... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver... A screwdriver used to facilitate implant insertion and removal was found to be out of specificati... Class II Trilliant Surgical, LLC
Mar 14, 2019 Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a ... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments f... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (St... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to b... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc

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.