Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 36121–36140 of 38,428 recalls
Recalled Item: Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201
The Issue: Customer complaint investigation confirmed the issue of false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test
The Issue: The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN (TM) L-P SCREW
The Issue: One batch of 4.5 mm diameter Trigen Low-Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used
The Issue: Roche investigation into complaints found Accu-Chek Inform II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner.
The Issue: Roche investigation into complaints found Accu-Chek Inform II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Cholestech LDX ALT AST Test Cassette
The Issue: The recall was initiated because Alere San Diego
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit model 8015 with software version 9.12 Product
The Issue: The recall was initiated because Carefusion has received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit model 8015 with software version 9.12 Product
The Issue: The recall was initiated because Carefusion has identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIMGUARD Container Filters
The Issue: Some individual container filter units might contain thin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1488 HD 3-Chip Camera
The Issue: In certain operating room environments, a colored screen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1488 HD 3-Chip Inline Camera
The Issue: In certain operating room environments, a colored screen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1488 HD 3-Chip Camera
The Issue: In certain operating room environments, a colored screen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntellVue Info Center iX 866023
The Issue: If a customer creates customized trend scales in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.