Browse Device Recalls
1,361 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,361 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 1,361 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2017 | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | The product has the potential to be non-sterile as it was not packaged in accordance to specifica... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jan 12, 2017 | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019... | The firm received a complaint alleging that a DRX Revolution System could not be stopped when app... | Class II | Carestream Health Inc |
| Jan 11, 2017 | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usag... | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OP... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 8, 2017 | Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 l... | The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might... | Class II | Laerdal Medical Corporation |
| Jan 5, 2017 | VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, I... | The company received a customer complaint for the inability to calibrate VITROS Chemistry Product... | Class III | Ortho-Clinical Diagnostics |
| Dec 21, 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP... | Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 21, 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3P... | Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2016 | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. ... | There is a potential for biased results to be generated over the 10 day on-analyzer storage limit... | Class II | Ortho-Clinical Diagnostics |
| Dec 8, 2016 | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usag... | There is a potential for variable negatively and positively biased urine protein results using VI... | Class II | Ortho-Clinical Diagnostics |
| Nov 29, 2016 | CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... | There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-8... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM M... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-8... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No.... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog ... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 Th... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 Th... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 22, 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) T... | Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 21, 2016 | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738... | Software error; Carestream Health Inc, received a complaint stating that when a user accidentally... | Class II | Carestream Health Inc |
| Nov 18, 2016 | IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay... | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Cat... | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 15, 2016 | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Onl... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 9, 2016 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product C... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Produc... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 6464... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Oct 26, 2016 | VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per ... | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products ... | Class III | Ortho-Clinical Diagnostics |
| Oct 21, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens rec... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 7, 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration o... | Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class II | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 19, 2016 | PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. T... | Product was found to contain excess residual levels of hydrogen peroxide. | Class II | Bausch & Lomb Inc Irb |
| Sep 7, 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 7, 2016 | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Dis... | Mislabeling of the "expiration date". The expiration date on the outer box and the individual po... | Class II | Ellman International, Inc. |
| Sep 7, 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Therm... | Ortho confirmed that it is possible for the mis-association of sample identification and assay re... | Class II | Ortho-Clinical Diagnostics |
| Aug 30, 2016 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 29, 2016 | CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-02... | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could resul... | Class II | ConMed Corporation |
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.