Kirwan 14-5011Recalls & reported problems
Kirwan Surgical Products LLC · Disposable Bipolar Pencil 5" (12.7cm) 25 Gauge Straight · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
6 other recalls cover devices cleared under the same FDA submission (K864402); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 14, 2024Open, Classified
Potential for the outer stainless-steel tube to break or detach.
Z-0654-2025 · Root cause: Device Design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K864402. One submission often covers many models, so check the product and lot details in each record.
- Z-0657-2025 · Nov 14, 2024 · Open, ClassifiedAmbler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tis
- Z-0658-2025 · Nov 14, 2024 · Open, ClassifiedWalcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, an
- Z-0660-2025 · Nov 14, 2024 · Open, ClassifiedOptikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, a
- Z-0659-2025 · Nov 14, 2024 · Open, ClassifiedNidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in e
- Z-0656-2025 · Nov 14, 2024 · Open, ClassifiedAccutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use i
- Z-0655-2025 · Nov 14, 2024 · Open, ClassifiedKirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.