Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 2, 2018 | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) | Device may provide inaccurate measurements. | Class II | Philips Consumer Lifestyle |
| Feb 2, 2018 | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... | This recall has been identified due to the batch being mislabeled, with the packaged component's... | Class II | Signature Orthopedics Pty Limited |
| Feb 2, 2018 | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patie... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 leve... | To correct the kit's instructions for use as the storage time for gastric and gastroesophageal ju... | Class II | Dako North America Inc. |
| Feb 2, 2018 | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | 3M Surgical Clipper Professional 9681 | Failure to follow proper charging practices can result in lithium-ion battery degradation, charac... | Class II | 3M Company - Health Care Business |
| Feb 2, 2018 | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids... | Supplier manufacturing defect with the syringe plunger tip. | Class II | Merit Medical Systems, Inc. |
| Feb 2, 2018 | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, on... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 1, 2018 | smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71... | The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short... | Class II | Smith & Nephew, Inc. |
| Feb 1, 2018 | SOMATOM Scope ( Model 10967666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 16 (10165977) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Spirit(Model 10045692 ) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope Power (Model 10967888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective (Model 10495568) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective 16 (Model 10891666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | Nicolet¿ Ambulatory EEG | Potential to be able to import an ambulatory exam for a patient for which the exam was not started. | Class II | Natus Neurology Inc |
| Feb 1, 2018 | SOMATOM Emotion 6 (Model 10165888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR ... | Packaged with an incorrect overwrap. | Class II | Medline Industries Inc |
| Jan 31, 2018 | StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)0082... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)008270025... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)108... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 31, 2018 | StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UD... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 31, 2018 | ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 31, 2018 | StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827... | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... | Class II | Cook Inc. |
| Jan 30, 2018 | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The kn... | Customers may receive the incorrect size implant from what is labeled on the box. | Class II | Howmedica Osteonics Corp. |
| Jan 30, 2018 | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 8... | Broken or missing screws and retaining clips. This may be due to screw tolerance and material st... | Class II | Encore Medical, Lp |
| Jan 30, 2018 | Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023,... | May produce erroneously low results from specific well sets. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 30, 2018 | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... | The firm received complaints regarding the incompatibility and dimensional interference between ... | Class II | Orthofix Srl |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000... | The device could have a missing spanner nut and snap ring which could potentially result in the e... | Class II | Stryker Communications |
| Jan 29, 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... | The device may process the same sample with two different sample IDs and sample information while... | Class II | Beckman Coulter Inc. |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M5... | May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard d... | Class II | NxStage Medical, Inc. |
| Jan 29, 2018 | Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter i... | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... | Class II | Philips Electronics North America Corporation |
| Jan 29, 2018 | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter i... | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... | Class II | Philips Electronics North America Corporation |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 26, 2018 | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, h... | The device power supply was not manufactured according to specification which can result in the l... | Class II | Inova Diagnostics Incorporated |
| Jan 26, 2018 | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, h... | The device power supply was not manufactured according to specification which can result in the l... | Class II | Inova Diagnostics Incorporated |
| Jan 26, 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imag... | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | Class II | Stryker Communications |
| Jan 26, 2018 | Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build... | Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment v... | Class II | RAYSEARCH LABORATORIES AB |
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.