Browse Device Recalls
1,382 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,382 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 1,382 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT COD... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E75... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUC... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, S... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, S... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE,... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 27, 2017 | Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ON... | A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 ma... | Class II | Welch Allyn Inc |
| Feb 21, 2017 | VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Ide... | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can ... | Class II | Ortho-Clinical Diagnostics |
| Feb 2, 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... | Multiple software issues, which may affect the operation and workflow of the system. Potential fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 1, 2017 | VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Cod... | Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. | Class II | Ortho-Clinical Diagnostics |
| Jan 31, 2017 | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with th... | Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adj... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 26, 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... | SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... | Class II | Baxter Healthcare Corporation |
| 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... |
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.