Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardio... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardio... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERA... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for c... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for c... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 15, 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardio... | There is a potential for extensive loss of primary segment material exposing underlying stainless... | Class I | Medtronic Vascular |
| Mar 13, 2019 | Procedure kits include devices from the affected lots distributed OUS only: ... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 12, 2019 | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... | Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... | Class II | Beaver Visitec |
| Mar 12, 2019 | Azurion FlexArm, 722079 | During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not accor... | Class II | Philips North America, LLC |
| Feb 28, 2019 | Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MR... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: Th... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 P... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product ... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a mul... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 19, 2019 | Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm... | The product contains a misprinted expiration date on the peel pack. Both were printed as "180615... | Class III | Beaver Visitec |
| Feb 15, 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed wit... | Class II | COVIDIEN LLC |
| Feb 8, 2019 | Omega Systems These devices are intended to be used in the environment whe... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 8, 2019 | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 6, 2019 | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical ... | Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfer... | Class II | Medica Corporation |
| Jan 29, 2019 | TASE 500 Imaging systems | the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... | Class II | COLLINS AEROSPACE |
| Jan 29, 2019 | TASE 400 Imaging systems | the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... | Class II | COLLINS AEROSPACE |
| Jan 25, 2019 | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:... | Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturin... | Class II | Philips North America, LLC |
| Jan 25, 2019 | Obturator (shortcone), Part number 26114 Product Usage: The obturator is ... | The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... | Class II | Medrobotics Corporation |
| Jan 25, 2019 | Fetal Spiral Electrode, Model No. 9898 031 37631 | During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain... | Class II | Philips North America, LLC |
| Jan 25, 2019 | Obturator (long cone), Part number 25162 Product Usage: The obturator is ... | The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... | Class II | Medrobotics Corporation |
| Jan 15, 2019 | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is ... | FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jan 9, 2019 | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30, Product 860306, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC20, Product 860332, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC50, Product 860310, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70, Product 860315, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 4, 2019 | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-... | The labeling of the boxes and sterile pouches did not match the contents. | Class II | Conformis, Inc. |
| Dec 27, 2018 | Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Pr... | Curity All Purpose Sponges were not sterilized and distributed | Class II | Cardinal Health 200, LLC |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 21, 2018 | DigitalDiagnost C50, Stationary X-ray System | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing... | Class II | Philips Healthcare |
| Dec 19, 2018 | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a poteas... | The kits may contain the incorrect number of components or the kits may be missing components. | Class II | Associates of Cape Cod, Inc. |
| Dec 18, 2018 | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: ... | There is a potential for a communication interruption following a bolus command that may result i... | Class II | Insulet Corporation |
| Dec 7, 2018 | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 1049... | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 7, 2018 | Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, 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.