Browse Device Recalls
3,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,550 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 3,550 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 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 5 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 7, 2012 | ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 7, 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set wi... | Devices leaking at the Y-site | Class II | Medical Specialties Distributors, Inc. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Jul 25, 2012 | Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... | Essenta DR C-Arm may fall | Class II | Philips Healthcare Inc. |
| Jul 25, 2012 | Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ... | Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board th... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2012 | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... | A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potent... | Class II | DePuy Spine, Inc. |
| Jul 17, 2012 | Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Number... | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insert... | Class II | Conformis Inc |
| Jul 17, 2012 | Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Num... | Syphilis Assay Interference with HBsAg Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 14, 2012 | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... | Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 14, 2012 | Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... | Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 11, 2012 | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dent... | Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for... | Class II | Straumann USA, LLC |
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.