Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.
The Arrow PICC Access Tray, REF ASK-04001-CG1, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 360 units affected.
Arrow spinal anesthesia kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 79,614 units are affected.
Arrow radial artery, arterial line and hydrophilic catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 37,738 units are affected.
Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 35,540 units are affected.
The Arrow two-lumen 14 Fr x 20 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,180 units affected.
Arrow paracentesis kits, REF AK-00376 and ASK-00376-VCU, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 50,724 units affected.
Arrow AGBA PICC G4 Stylet kits and VPS access kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 11,358 units affected.
Arrow SAC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
Arrow radial and arterial catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 310,606 units affected.
Arrow hemodialysis and AHDC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 62,719 units affected.
Arrow midline catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 177,014 units are affected.
Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.
Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 308,263 units affected.
Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.
Arrow PSI and PSI/CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 348,684 units are affected.
The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.
A further group of Arrow PSI kits is being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 72,354 units are affected.
Arrow radial artery catheter and arterial line kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 785,999 units affected.
Arrow access trays and StimuCath safety kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 205,685 units affected.
Arrow Pacing/PSI kits, 5 Fr two-lumen, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 95 units affected.
The Arrow peritoneal lavage catheter kit, 8 Fr, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 7,560 units affected.
Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 3,481 units affected.
Arrow AHDC three-lumen catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 4,270 units affected.
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