Philips Respironics DreamWear Full Face Mask recall — FDA Z-1781-2022
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Complete FDA and NHTSA recall records dated in October 2022.
These records include useful source details for the selected month.
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.
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…
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.
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.
Potential for leakage at the catheter hub.
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…
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…
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
High bacterial growth within products
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Product does not declare the allergens of wheat and soy on label.
Product contains undeclared peanuts.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are being recalled.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.