Breg Inc
Carlsbad, CA, US
BREG, INC., appears in FDA device records in Carlsbad, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Breg Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Breg Inc, An Orthofix Companyenforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Breg Inc in 2019.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2028253 | 1000125378 | BREG, INC., | 2382 Faraday Avenue, Carlsbad, CA 92008 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KYRBag, Ice
- FSDBinder, Abdominal
- IODComponents, Exercise
- IPMCover, Limb
- KICCushion, Flotation
- KYSInsoles, Medical
- ITWJoint, Ankle, External Brace
- ITSJoint, Hip, External Brace
- ITQJoint, Knee, External Brace
- IRPMassager, Powered Inflatable Tube
- KTDOrthosis, Abdominal
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPXOrthosis, Rib Fracture, Soft
- IPTOrthosis, Thoracic
- MRIOrthosis, Truncal/Orthosis, Limb
- IMEPack, Hot Or Cold, Reusable
- ILOPack, Hot Or Cold, Water Circulating
- IPGShoe, Cast
- JOWSleeve, Limb, Compressible
- ILISling, Arm
- ILESling, Arm, Overhead Supported
- IQJSplint, Clavicle
- ILHSplint, Hand, And Components
- IQMSplint, Temporary Training
- IOYSupport, Arm
- KGXTape And Bandage, Adhesive
- HXTTape, Orthopedic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0231-2024 | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. | Class II | Open, Classified | |
| Z-1908-2017 | If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1907-2017 | Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1906-2017 | Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1905-2017 | Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1904-2017 | Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1903-2017 | Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1902-2017 | Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1901-2017 | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | Class II | Terminated | |
| Z-1447-2014 | K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support. | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. | Class II | Terminated | |
| Z-1446-2014 | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. | Class II | Terminated | |
| Z-0804-2013 | BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect. | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. | Class II | Terminated | |
| Z-0803-2013 | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. | Class II | Terminated | |
| Z-2326-2012 | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin. | This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled. | Class II | Terminated | |
| Z-1989-2009 | Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low voltage power to the Kodiak unit. The power supply is not used with other Polar Care models such as PC300 and PC500. | Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain