All Recalls

95,064 total recalls in our database

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Jan 2, 2019 Surgical Instruments Nationwide View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).

Dec 26, 2018 Other Medical Devices Nationwide View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Dec 28, 2018 Surgical Instruments View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →
🏥 Medical Devices Class I - Dangerous

4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.

Nov 9, 2018 Other Medical Devices Nationwide View Details →

Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.

Dec 17, 2018 Diagnostic Equipment View Details →

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

Jan 3, 2018 Surgical Instruments Nationwide View Details →

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Dec 28, 2018 Surgical Instruments View Details →

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Dec 28, 2018 Surgical Instruments View Details →

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Dec 28, 2018 Surgical Instruments View Details →

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Dec 21, 2018 Patient Monitors View Details →