Browse Device Recalls
67 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 67 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 67 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Jul 11, 2016 | Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: ... | Possible dull knife edge | Class II | Bausch & Lomb Inc Irb |
| Jul 11, 2016 | Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to... | Possible dull knife edge | Class II | Bausch & Lomb Inc Irb |
| Sep 3, 2015 | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biot... | The firm determined that 25 lots had been manufactured with a minor surface defect occurring in t... | Class II | Bausch & Lomb Inc Irb |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Sep 25, 2014 | Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Dis... | Product lot did not meet the specification for its disinfectants at the time of manufacture. | Class II | Bausch & Lomb Inc- Greenville Solutions Plant |
| Apr 21, 2014 | Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile. | Out of specification results for one of the two disinfectants. | Class II | Bausch & Lomb Inc- Greenville Solutions Plant |
| Aug 31, 2012 | Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Modu... | Posterior fluidics modules installed in the system may need to be recalibrated. | Class II | Bausch & Lomb 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.