Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 4, 2026 | LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. | In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wro... | Class III | Magellan Diagnostics, Inc. |
| Aug 31, 2026 | Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | T1 Patient Monitor. Operator's Manual: T1 Patient Monitor | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneView Series. Operator's Manuals: T5 / T8 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panora... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Jul 27, 2026 | HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P ... | Products were distributed without the required Maintenance Supplement, which describes an extra c... | Class III | HeartSine Technologies Ltd |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catal... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Cat... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 9, 2026 | Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 2... | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March... | Class III | Medical Action Industries, Inc. 306 |
| Jun 26, 2026 | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 1044539... | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant C... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jun 26, 2026 | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Ca... | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Cali... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 25, 2026 | Heraeus, PALAMIX uno. Material Number: 66057893. | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... | Class III | Heraeus Medical GmbH (Dental Division) |
| Mar 25, 2026 | Heraeus, PALAMIX duo. Material Number: 66057897. | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... | Class III | Heraeus Medical GmbH (Dental Division) |
| Feb 6, 2026 | Battery Charging Station; Model: 0998-00-0802; | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ... | Class III | Datascope Corp. |
| Jan 6, 2026 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magen... | Class III | Straumann USA LLC |
| Nov 18, 2025 | HemosIL SynthAFax. Partial Thromboplastin Time Tests. | Recalled lots were manufactured with double the amount of preservative concentration. | Class III | Instrumentation Laboratory |
| Nov 3, 2025 | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Oct 23, 2025 | Cardiosave Rescue | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Datascope Corp. |
| Oct 23, 2025 | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Datascope Corp. |
| Oct 21, 2025 | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415... | Due to an device without a premarket clearance being incorrectly package and distributed. | Class III | Accriva Diagnostics, Inc. |
| Oct 6, 2025 | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... | A labeling error was identified on the affected product. The expiration date on the kit box label... | Class III | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P... |
| Sep 5, 2025 | Philips X7-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips 3D6-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips C9-4 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips L12-5 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips OMNI III TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips Mini Multi TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips L17-5 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips OMNI II TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips X3-1 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips S4-1 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips S5-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 36... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 36... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 56... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 860010-1L | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360020-1EP | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360020-1P | The device does not bear a unique device identifier. | Class III | Penner Patient Care, 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.