All Recalls

Lack of Processing Controls

Subpotent Drug

AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.

Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.

Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.

Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.

Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.

Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.

Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.

Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).

ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".

Products are marketed without a cleared 510k.

First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.

Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).

The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.