Cook Inc. Recalls StoneBreaker Probe Caps Due to Sterility Concerns
Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the failure to achieve appropriate sterility presents a risk of harm (infection), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 370 units of the StoneBreaker Probe Cap (Catalog number: SBA-PC; GPN: G52601; UDI: (01)00827002526013). The recall covers all lots of the product.
The recall was initiated because the interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions provided in the Instructions for Use. This issue could potentially affect the safety of the device during medical procedures.
The product was distributed nationwide in the United States and in numerous countries internationally, including Canada, Australia, and various nations in Europe, Asia, and the Americas. Healthcare providers and facilities that have received these devices should stop using them and contact Cook Inc. for further instructions on the recall process.
The recalled product
- Product
- StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
- Manufacturer
- Cook Inc.
- Affected units
- 370
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateCook Inc. Recalls Endoscopic Introducer/Extractor Due to Inadequate Reprocessing Instructions
FDA (Devices) · 2017-06-21
- ModerateCook Inc. Recalls Clarke-Reich Laparoscopic Knot Pushers Due to Reprocessing Issues
FDA (Devices) · 2017-06-21
- ModerateCook Inc. Recalls Stamey Needles Due to Insufficient Reprocessing Instructions
FDA (Devices) · 2017-06-21
- HighCook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
FDA (Devices) · 2019-11-27
- HighCook Inc. Recalls Pereyra Ligature Carrier 75 Due to Reprocessing Instructions
FDA (Devices) · 2017-06-21
- ModerateCook Inc. Recalls Pereyra-Raz Ligature Carriers Due to Inadequate Reprocessing Instructions
FDA (Devices) · 2017-06-21