Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-10-07FDA-DevicePhilips North America, LLCClass IIProxiDiagnost N90
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
- 2020-10-07FDA-DeviceEncore Medical, LPClass IIRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
- 2020-10-07FDA-DeviceEncore Medical, LPClass IIRSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
- 2020-10-07FDA-DeviceExactech, Inc.Class IIEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
- 2020-10-07FDA-DeviceExactech, Inc.Class IIEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
- 2020-10-07FDA-DeviceNorth American Rescue LLC.Class II4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947
Lack of sterility assurance of the 30-0171
- 2020-10-07FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
- 2020-10-07FDA-DeviceCardinal Health 200, LLCClass IIKIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
- 2020-10-07FDA-DeviceStryker Medical Division of Stryker CorporationClass IIStryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
- 2020-10-07FDA-DeviceRiverpoint Medical, LLCClass IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
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