Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-09-08FDA-DeviceCardiovascular Systems IncClass IISTEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
- 2021-09-08FDA-DeviceCardiovascular Systems IncClass IIDIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
- 2021-09-08FDA-DeviceMY01, INC.Class IIMY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.
- 2021-09-08FDA-DeviceZeltiq Aesthetics, IncClass IICoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.
- 2021-09-08FDA-DeviceThera Test Laboratories, Inc.Class IIEL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
- 2021-09-08FDA-DeviceThera Test Laboratories, Inc.Class IIEL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
- 2021-09-08FDA-DeviceOlympus Corporation of the AmericasClass IIGyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
- 2021-09-08FDA-DeviceBaxter Healthcare CorporationClass IIBaxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
- 2021-09-08FDA-DeviceBaxter Healthcare CorporationClass IIBaxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DeviceCovidien, LPClass IIPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- 2021-09-08FDA-DevicePhilips Medical Systems Gmbh, DMCClass IICombiDiagnost R90 Software Version R1.0 and R1.1
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
- 2021-09-01FDA-DeviceEthicon Endo-Surgery IncClass IIHARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
- 2021-09-01FDA-DeviceEthicon Endo-Surgery IncClass IIHARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief