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 36181–36200 of 38,428 recalls
Recalled Item: Cooper Surgical Cube Pessary 1 5/8""
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Incontinence Dish Folding Pessary #0
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Incontinence Ring Flexible Pessary #4
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Gellhorn Flexible Pessary -2 3/4"
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Incontinence Dish w/ Support Pessary #5
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTIO Inc.
The Issue: INTIO Inc. distributed a SVM User's Manual and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TotalCare SpO2RT2 bed. Product Usage: Bed
The Issue: In certain situations a software problem with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap Extended Life PD Transfer Set (6") with Twist Clamp.
The Issue: Labeling Revision: Additional instructions for the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended
The Issue: Labeling Revision: Additional instructions for the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160.
The Issue: Labeling Revision: Additional instructions for the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap Extended Life PD Transfer Set Extra Short (4") with
The Issue: Labeling Revision: Additional instructions for the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
The Issue: Glucose test strips reports no result message when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog #
The Issue: Glucose test strips reports no result message when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeScan brand OneTouch¿ Select Control Solution
The Issue: When OneTouch¿ Ultra and OneTouch¿ Select test strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duane Reade TRUEtrack monitor kit
The Issue: Meter kit outer boxes containing 10 ct. test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeScan brand OneTouch¿ Ultra Control Solution
The Issue: When OneTouch¿ Ultra and OneTouch¿ Select test strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReClaim Reamer Extension
The Issue: The tabs on the reamer extension device have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GOPump Elastometric infusion PumpKit with/ and without accesssories all...
The Issue: Received 2 complaints out of 458 distributed pumps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control
The Issue: Elevated MCV results on the 1311-682, 1311-683, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments....
The Issue: Stryker received reports from the field indicating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.