Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 5, 2024 | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device use... | Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Int... | Class II | Beckman Coulter, Inc. |
| Mar 5, 2024 | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been ... | Class II | Unomedical A/S |
| Mar 5, 2024 | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests | There are two windows on the test device, the control line window and the test results window. Th... | Class II | Quidel Corporation |
| Mar 4, 2024 | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... | Class II | X-NAV Technologies, LLC |
| Mar 4, 2024 | Alinity i Anti-HCV Reagent Kit, List Number 08P0521 | Customer complaints were received regarding falsely elevated results for some patient samples. In... | Class II | Abbott GmbH |
| Mar 4, 2024 | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are o... | Class II | Ion Beam Applications S.A. |
| Mar 4, 2024 | EZ2 Connect MDx-IVD Designed to perform automated isolation and purification ... | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERRO... | Class II | Qiagen Sciences LLC |
| Mar 4, 2024 | ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 | Customer complaints were received regarding falsely elevated results for some patient samples. In... | Class II | Abbott GmbH |
| Mar 4, 2024 | X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... | Class II | X-NAV Technologies, LLC |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators use... | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference mat... | Class II | Randox Laboratories Ltd. |
| Mar 1, 2024 | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... | Potential for positively biased results due to signal reduction over shelf life. | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 1, 2024 | Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| 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 | 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. |
| 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 | 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 | 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 | 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 | 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 |
| 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 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 | 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 | Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model ... | This recall has been reported retroactively. The power wheelchair firmware lacks a speed restrict... | Class II | Permobil Inc |
| 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 | 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-T10BTS | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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-T10BT | 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 (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 27, 2024 | Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... | 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 CLUSTER48D- 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 CLUSTER66H- 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 CLUSTER48D-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.