Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040.... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 13, 2009 | Sunquest Encompass The reporting site is using the Encompass software in a... | Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect ... | Class III | Sunquest Information Systems, Inc. |
| Jun 20, 2008 | Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... | Class III | Orthosoft, Inc. dba Zimmer CAS |
| Jun 6, 2006 | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ... | The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 in... | Class III | Radiometer America 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.