All Recalls

95,114 total recalls in our database

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Aug 18, 2020 Other Medical Devices Nationwide View Details →

Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10BUP-DX/ "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 10 Drug Detection: Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, and Tricyclic Antidepressant", X11-IS5 M-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS5 M-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100"

Ameditech

🏥 Medical Devices Class I - Dangerous

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Aug 18, 2020 Diagnostic Equipment Nationwide View Details →

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Aug 12, 2020 Infusion Pumps Nationwide View Details →

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Aug 18, 2020 Other Medical Devices Nationwide View Details →

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Aug 12, 2020 Infusion Pumps Nationwide View Details →

The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.

Sep 8, 2020 Diagnostic Equipment Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

Aug 7, 2020 Other Medical Devices View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Aug 12, 2020 Infusion Pumps Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Aug 12, 2020 Infusion Pumps Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Aug 3, 2020 Other Medical Devices Nationwide View Details →