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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

Clear
DateProductReasonClassFirm
May 11, 2018 Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR C... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle El... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shroude... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use ... The Tyvek pouch label for this device states: 'with holster'; however, this product does not com... Class II PSC Industries Inc
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Ele... The carton label for this device has the manufacturer symbol where the expiration date symbol sho... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipol... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use S... Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device ... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipo... Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in tha... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Us... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries 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.