Browse Device Recalls

48 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 48 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 48 FDA device recalls.

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Date	Product	Reason	Class	Firm
Mar 3, 2017	LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (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 2.75PAR (6/BOX), REF/PRODUCT CODE E757...	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, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(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, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, 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, CRESCENT KNIFE 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, 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
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

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.