Breg, Inc.
Breg, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2019, with 13 FDA device recalls on record.
Top product codes for Breg, Inc.
FDA recalls by Breg, Inc.
10 most recent of 13- Z-0231-2024 — BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Z-1446-2014 — Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Breg, Inc.
- K183702 — Polar Care Wave
- K070402 — MODIFICATION TO POLAR CARE 500
- K041714 — E-PAIN CARE
- K020988 — PAIN CARE 4200
- K013928 — PAIN CARE 3200
- K003611 — PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
- K002073 — PAIN CARE 3000
- K002321 — PAIN CARE 2000L
- K983454 — PAIN CARE 2000
- K963596 — POLAR CARE 300
- K961855 — POLAR CARE (MODEL 500/50000)
- K950755 — FLEXMATE K500
- K920581 — POLAR PAD (STERILE)
- K911795 — KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
- K914434 — POLAR PADS
- K913729 — POLAR PUMP, MODEL 500
Data sourced from openFDA. This site is unofficial and independent of the FDA.