Westmed REF 0562K recall — FDA Z-0745-2021
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative…
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative…
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
Gauze sponges contained in custom kits may be flaking or fraying.
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
Unapproved pesticide-ethylene oxide in sesame seeds from India used in the production of flour in bread ingredient Multigrain Solene Figotte (seeds bread) imported from France.
An internal quality review found that an ingredient contained a milk derivative, but milk was not declared on the label.
Firm routine testing resulted in a positive result for Listeria monocytogenes in one bag of frozen edamame.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Presence of Particulate Matter - found in reserve sample vials at the firm.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Browse recent months with enough recall history for useful comparison.