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.

2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceCovidien LLCClass II
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
2020-02-26FDA-DeviceSmith & Nephew, Inc.Class II
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
2020-02-26FDA-DevicePhilips North America LLCClass II
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
2020-02-26FDA-DevicePhilips North America LLCClass II
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
2020-02-26FDA-DeviceTELEFLEX MEDICAL INCClass II
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-02-26FDA-DeviceTELEFLEX MEDICAL INCClass II
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-02-26FDA-DevicePentax of America IncClass II
Pentax Video Colonoscope Model: EC38-i10L
Distributed in the USA without an approved 510K
2020-02-26FDA-DevicePentax of America IncClass II
Pentax Video Colonoscope Model: EC34-i10L
Distributed in the USA without an approved 510K
2020-02-26FDA-DeviceTheralase Inc.Class III
TLC-2000 Therapeutic Medical Laser System
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
2020-02-26FDA-DeviceAbbott Point Of Care Inc.Class II
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
2020-02-26FDA-DeviceCOVIDIEN LLCClass II
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
2020-02-26FDA-DeviceAbbott Point Of Care Inc.Class II
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.

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