FDA medical device recalls

Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality issues in multiple drainage, thoracentesis, and pneumothorax kits. If these injectable products lost sterility during manufacturing or storage, they could cause serious infection or treatment failure.

Arrow International hemodialysis kits contain anesthetic and saline solutions from a supplier with quality control problems and reports of drug ineffectiveness. If the sterility of these injectable products is compromised, patients could face serious or life-threatening complications.

Arrow International's 8FR peritoneal lavage catheter kits contain anesthetic medications (lidocaine and bupivacaine) from a supplier with known quality issues. If the sterility of these injectable components is compromised, patients could face serious injury or infection.

Arrow International JACC catheter kits contain lidocaine, bupivacaine, and sodium chloride from a supplier with quality control problems. The injectable components may not work properly or could be sterile-compromised, risking serious infection if used.

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in multiple PICC and JACC catheter kits. The anesthetic and saline components may be ineffective or contaminated, which could cause serious infection or other life-threatening complications if used.

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in multiple catheter and arterial line kits. The supplier's products showed signs of ineffectiveness and potential sterility problems, which could cause serious harm if compromised injectable products are used.

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality problems in multiple central venous catheter kits. The supplier's products had reports of ineffectiveness, and if sterility is compromised, these injectable drugs could cause serious infection or other life-threatening complications.

Arrow International included anesthetic and saline components from a supplier with quality issues in several percutaneous central venous catheter (CVC) kits. The supplier's products showed limited reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality issues in several catheter kit models. If the sterility of these water-based injectable products is compromised, patients could face serious or life-threatening infections.

Arrow International hemodialysis kits contain lidocaine, bupivacaine, and saline solution from a supplier with quality control problems. The contaminated materials may not work as intended, and compromised sterility in injectable products could cause serious harm to patients.

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality problems into hemodialysis kits. The supplier's products may not be sterile or effective, which could cause serious injury if used.

Arrow International included anesthetic medications (lidocaine, bupivacaine) and saline from a supplier with quality issues in multiple epidural catheter kits. The supplier's products may not be sterile or effective, and compromised sterility in injectable products can cause serious infection or other life-threatening complications.

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in multiple PICC (peripherally inserted central catheter) kit models. The supplier's products may be ineffective or contaminated, and compromised sterility in injectable products can cause serious infection or injury.

Arrow International recalled multiple central venous catheter kits that contain lidocaine, bupivacaine, and saline solution from a supplier with quality issues. The supplier's products may have compromised sterility, which could reduce drug effectiveness and pose serious health risks if the injectable solution is contaminated.

Arrow International included lidocaine, bupivacaine, and saline solutions from a supplier with known quality problems in multiple arterial and radial artery catheter kits. The supplier's medications showed signs of ineffectiveness, and if the sterility of these injectable products was compromised, patients could face serious injury.

Arrow International recalled several PICC (peripherally inserted central catheter) kits and stylets because they contain injectable medications from a supplier with quality issues. The medications—lidocaine, bupivacaine, and saline—may be ineffective or contaminated, which could cause serious injury if used.

Arrow International included local anesthetic drugs (lidocaine and bupivacaine) from a supplier with quality issues into several pacing procedure kits. The supplier's drugs had limited reports of ineffectiveness, and compromised sterility in injectable products could cause serious infection or other life-threatening complications.

Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality problems in its biopsy system kits. The supplier had reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

Arrow International included lidocaine, bupivacaine, and saline solutions from a supplier with quality problems in multiple anesthesia and nerve block kits. The supplier's products may be ineffective or contaminated, which could cause serious infection or other life-threatening complications if the sterility of these injectable solutions is compromised.

Arrow International paracentesis kits (models AK-00376 and ASK-00376-VCU) contain anesthetic and saline solutions from a supplier with quality issues and reports of drug ineffectiveness. If the sterility of these injectable products is compromised, they could cause serious or life-threatening infections or complications during the procedure.

A software error in certain Automated Impella Controller devices (used to manage left heart support blood pumps) may affect device function. The error affects controllers with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above across multiple regions worldwide.

A blender component in certain Datex-Ohmeda Panda Freestanding Warmers can loosen over time, causing the device to deliver oxygen at a concentration that does not match the setting the user selected. This can result in infants receiving too much or too little oxygen, potentially causing harm.

A component in certain Giraffe and Panda warming systems can loosen during maintenance, causing the device to deliver oxygen at a concentration different from what the clinician set. This can result in too much oxygen (hyperoxia) or too little oxygen (hypoxia) being delivered to the patient.

A component in certain Giraffe Stand-alone Infant Resuscitation Systems can loosen during maintenance, causing the device to deliver oxygen at the wrong concentration. Infants may receive too much or too little oxygen, risking serious harm.

Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.

AVID Medical, Inc. distributed 60 kits of Halyard Eye Bag Pack (Kit Code UIEB48-01) with sealed pouches that did not undergo validated sterilization. The affected kits were distributed nationwide in Iowa. No injuries have been reported.

Halyard Drape Pack kits (Code LMDP36-01) were distributed without proper sterilization validation. Approximately 72 kits shipped with sealed pouches that had not undergone the required sterilization process. These kits were distributed nationwide and in Iowa.

AVID Medical inadvertently distributed 224 kits of Halyard Towel Six Pack (Kit Code AMTS70-01) with sealed pouches that had not undergone validated sterilization. The affected kits were distributed nationwide, with concentration in Iowa. No injuries have been reported.

AVID Medical distributed 120 sealed Halyard Pain Pack kits (Kit Code AMPK48-01, Lot 334669) that did not undergo proper sterilization validation. The affected kits were distributed nationwide, with known distribution in Iowa. No injuries have been reported.

Elekta's MOSAIQ Oncology Information System software (version 3.2) may fail to load an adapted baseline shift plan during cancer treatment delivery if a communication error occurs. This could affect the accuracy of radiation therapy positioning. No injuries have been reported.