Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,781 detailed records are currently available in this category.
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates…
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include…
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as…
Potential for leakage at the catheter hub.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date…
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem…
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem…
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
