Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2024 | Mojo 2 Full Face Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Mar 1, 2024 | Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | 25-LHP-828, HeNe Laser System, 35 mW | These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each l... | Class II | PACIFIC LASERTECH, LLC |
| Mar 1, 2024 | Mojo Non Vented Full Face Mask with Headgear, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray | Trumpet Needle Guide ring can detach when excessive pressure is applied. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 1, 2024 | Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Dilator - Intended to be used for dilating puncture sites or catheter tracts ... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... | Trumpet Needle Guide ring can detach when excessive pressure is applied. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 1, 2024 | Mojo 2 Full Face Non Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | iQ 2 Nasal Vented Mask | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | N-LHP-928, HeNe Laser System, 35 mW | These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each l... | Class II | PACIFIC LASERTECH, LLC |
| Mar 1, 2024 | Mojo 2 Full Face AAV Non Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | 25-LHP-928, HeNe Laser System, 25 mW | These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each l... | Class II | PACIFIC LASERTECH, LLC |
| Mar 1, 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an op... | Class II | Alere San Diego, Inc. |
| Feb 29, 2024 | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix ... | Products were found to have confirmed drug cross contamination prior to release may lead to incor... | Class II | Becton Dickinson & Co. |
| Feb 29, 2024 | BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix ... | Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 i... | Class II | Becton Dickinson & Co. |
| Feb 29, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometri... | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) ass... | Class II | Beckman Coulter, Inc. |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 28, 2024 | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 28, 2024 | Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b)... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alph... | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Feb 28, 2024 | Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNB... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | VITROS Performance Verifier II | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... | Class II | Ortho-Clinical Diagnostics |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | O.T.D - Optimum Traction Device - Street Orange. Single use traction splint. | Failure of adhesive to secure the pole insert. | Class II | Emergency Products & Research |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | VITROS Performance Verifier I | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... | Class II | Ortho-Clinical Diagnostics |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
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.