Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-06-26FDA-DeviceCook Inc.Class IIZenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
- 2019-06-26FDA-DeviceCytocell Ltd.Class IIIAquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.
There is an error in the chromomap on the package insert.
- 2019-06-26FDA-DeviceEthicon, Inc.Class IIETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- 2019-06-26FDA-DeviceEthicon, Inc.Class IIETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- 2019-06-26FDA-DeviceCooperSurgical, Inc.Class IILEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRAT
2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
- 2019-06-26FDA-DeviceGE Healthcare, LLCClass IILVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultra
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
- 2019-06-26FDA-DeviceMicrobiologics IncClass IIICepheid Xpert C. difficile/Epi Control Panel
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
- 2019-06-26FDA-DeviceMed Tec IncClass IICIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
- 2019-06-26FDA-DeviceCovidien LLCClass IISIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IISIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IISIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IISIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IISIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA45 CT AR MD THK REL, EGIA45CTAMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceCovidien LLCClass IIEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- 2019-06-26FDA-DeviceMako Surgical CorporationClass II2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
The bearings of the saw attachments were ungreased.
- 2019-06-26FDA-DeviceMako Surgical CorporationClass II2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
The bearings of the saw attachments were ungreased.
- 2019-06-26FDA-DeviceArrow International IncClass IIArrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
Lidstock states the incorrect expiration date for the product
- 2019-06-26FDA-DeviceArrow International IncClass IIArrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
Lidstock states the incorrect expiration date for the product
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