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 |
|---|---|---|---|---|
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with AXIOM Se... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with Sensis Hi... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circula... | Devices were labeled with an expiration date of four years and ten days rather than the validated... | Class II | W.L. Gore & Associates, Inc. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B-Intended to be used as a diag... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... | Class II | Argon Medical Devices, Inc |
| Jul 2, 2024 | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip... | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). T... | Class II | Zimmer, Inc. |
| Jul 2, 2024 | Luminos dRF Max- Intended to visualize anatomical structures by converting an... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Multitom Rax -Intended to visualize anatomical structures by converting an x-... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Luminos Agile Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telem... | Class II | Stryker Sustainability Solutions |
| Jul 2, 2024 | LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | Class II | Neurovision Medical Products Inc |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | W L Gore & Associates, Inc. |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | W L Gore & Associates, Inc. |
| Jun 28, 2024 | IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x ent... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Pr... | Class II | Baxter Healthcare Corporation |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261,... | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... | Class II | Boston Scientific Corporation |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 | The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of t... | Class II | LINK BIO CORP |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION ... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD | Their is a potential for high background and off-target staining when using the monoclonal primar... | Class II | Ventana Medical Systems, Inc. |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Sut... | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... | Class II | Boston Scientific Corporation |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/60... | If temperature management system fails to reach correct target water temperature while device is ... | Class II | Medivance Inc. |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 26, 2024 | ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | ARTIS is a family of dedicated angiography systems developed for single and b... | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... | Class II | Siemens AG/Siemens Healthcare GmbH |
| Jun 26, 2024 | ARTIS is a family of dedicated angiography systems developed for single and b... | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... | Class II | Siemens AG/Siemens Healthcare GmbH |
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.