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.

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DateProductReasonClassFirm
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
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

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.