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.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 26mm stop, 1.4x81mm, AO, Item Number 502015146
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 2.5x135mm, AO, Item Number 502015142
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 2.5x87mm, AO, Item Number 502015137
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 2.5x94mm, Stryker, Item Number 502015136
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 15mm stop, 1x76mm, AO , Item Number 502015115
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill Sys2.7, 2x103mm, AO, Item Number 502015107
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceZimmer GmbHClass IIDrill Sys 2.7, 2x105mm, stryker, Item Number 502015106
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- 2019-05-29FDA-DeviceElekta Instrument ABClass IILeksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
- 2019-05-29FDA-DeviceOakworks IncClass IIOAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Tabl
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceRemel IncClass IIThio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
- 2019-05-29FDA-DeviceBoston Scientific CorporationClass IIAURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaec
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
- 2019-05-29FDA-DeviceBoston Scientific CorporationClass IIAURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecolo
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
- 2019-05-29FDA-DeviceBoston Scientific CorporationClass IIAURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT,
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
- 2019-05-29FDA-DeviceBoston Scientific CorporationClass IIAURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecol
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
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