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 |
|---|---|---|---|---|
| Mar 3, 2017 | LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT C... | 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, 2.2 MM 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, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, ... | 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, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT C... | 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, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A,... | 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, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E... | 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, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STE... | 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, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A... | 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, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, ... | 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, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7... | 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 DN (6/BOX), REF/PRODUCT CODE E7510D,... | 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, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT C... | 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, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A... | 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 BEVEL UP GUARDED (6/BOX), REF/PROD... | 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 (6/BOX), REF/PRODUCT CODE E7530, STERI... | 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, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, ... | 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 CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A... | 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 CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, ... | 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, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A... | 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 CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, ... | 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, 2.6 MM 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, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODU... | 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, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT C... | 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 CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT C... | 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, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E760... | 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, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, ... | 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, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, ... | 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, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERI... | 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, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT C... | 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 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 |
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.