Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Roche Molecular Systems
Class I - Dangerous
Kit labeled with the incorrect expiration date.
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Class I - Dangerous
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
5.0mm Round Fluted Bur, Super Long
Stryker Instruments Div. of Stryker
Class I - Dangerous
Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Musculoskeletal Transplant Foundation
Class I - Dangerous
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.
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Lifeline First Aid
Class I - Dangerous
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.
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class I - Dangerous
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, Discovery MR750w
GE Healthcare
Class I - Dangerous
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.
Class I - Dangerous
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.
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
Karl Storz Endoscopy
Class I - Dangerous
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).
Class I - Dangerous
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.
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
The Anspach Effort
Class I - Dangerous
Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
Class I - Dangerous
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.