Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assa... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 5, 2012 | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B T... | Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold th... | Class II | SpineFrontier, Inc. |
| Sep 25, 2012 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Po... | Class II | Belmont Instrument Corporation |
| Sep 17, 2012 | Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, mono... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These sy... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPID... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoi... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15)... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical dev... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These ... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 14, 2012 | AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identific... | Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P... | Class II | Advandx Inc |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4... | InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ... | Class II | Hologic, Inc. |
| Sep 14, 2012 | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identific... | GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomona... | Class II | Advandx Inc |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an... | Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b... | Class II | Hologic, Inc. |
| Sep 12, 2012 | Philips Digital Diagnost with patient carriage Model: 712050 with serial nu... | Hook does not securely hold the footplate in vertical position, causing the footplate to disengag... | Class II | Philips Healthcare Inc. |
| Sep 11, 2012 | Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... | HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... | Class II | Philips Healthcare Inc. |
| Sep 11, 2012 | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) ... | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 6, 2012 | SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRA... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK ... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anc... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK ... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK ... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anc... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRA... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRA... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK ... | Fracture of SPIRALOK Anchors post op, requiring patient revision | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Sep 6, 2012 | Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... | The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and ... | Class II | Philips Healthcare Inc. |
| Aug 29, 2012 | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-hand... | During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. | Class II | SpineFrontier, Inc. |
| Aug 28, 2012 | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compresso... | Inspan Compressors may break at weld causing a loss of compression | Class II | SpineFrontier, Inc. |
| Aug 22, 2012 | S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223... | When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a kno... | Class II | SpineFrontier, Inc. |
| Aug 16, 2012 | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... | Shipped with incorrect software | Class II | ZOLL Medical Corporation |
| Aug 15, 2012 | Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... | Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wa... | Class II | Philips Healthcare Inc. |
| Aug 14, 2012 | Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... | Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (... | Class II | Philips Healthcare Inc. |
| Aug 10, 2012 | Capsule Neuron Docking Station, a component in the DataCaptor Connectivity Sy... | Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or los... | Class II | Capsule Tech Inc. |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
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.