Browse Device Recalls
4,606 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,606 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 4,606 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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 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 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 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 400mm Straight Rod, Part Number: 60101-400. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Jan 5, 2009 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Oct 13, 2008 | Quadra S Offset Broach Handle The offset broach handle is intended to atta... | Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potent... | Class II | Medacta Usa Inc |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 36... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 33... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| May 13, 2008 | TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanne... | The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis... | Class II | Toshiba American Medical Systems 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.