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.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20 (INTL) N, Part Number CS08652
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US)M REFURBISHED, Part Number CS78653
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) N REFURBISHED, Part Number CS78651
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) M TO MASIMO, Part Number CS08750
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) M W/PRINTER, Part Number CS08659
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (US) M, Part Number CS08653
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (US) N, Part Number CS08651-01
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20 (US) N, Part Number CS08651
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceLeica Microsystems, Inc.Class IILeica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIDermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIDermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIKerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIKerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIKerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIKerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Potential for product sterility breach due to a compromised or pinched seal defect
- 2018-10-10FDA-DeviceExactech, Inc.Class IIEquinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
- 2018-10-10FDA-DeviceEllex iScience, Inc.Class IIellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Sterility failure found in one of the units in the lot.
- 2018-10-10FDA-DeviceRadiometer America IncClass IIABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again
- 2018-10-10FDA-DeviceEndologixClass IENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-2
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.
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