US: 4 medical device contamination recalls, Sept 2026: what to check

The US FDA published 4 contamination recall events covering 13 medical device product lines between September 16 and 23, 2026, with 2 classified as serious. The recalls target IV sets and Plum administration sets from ICU Medical, Pericare-wipe Foley and catheter trays from C.R. Bard, a Halyard IV start kit from AVID Medical, and a Bravo CF capsule from Given Imaging, spanning four distinct contamination mechanisms.

US hospital distributors, group purchasing organizations, importers and manufacturers of intravascular and urological devices must immediately check stock against the recalled lines, review supplier test reports and batch records, and confirm 21 CFR Part 806 and Part 803 reporting compliance, or face continued FDA recall action, product withdrawal, patient injury, and reporting penalties for failures to report.

• Window : September 16 to 23, 2026
• Alerts : 4 recall events, 13 product lines, 2 serious, US FDA enforcement
• Risk : contamination (surface, PVC particulate, microbial, attachment failure)
• Product family : medical devices (IV sets, catheter trays, IV start kits, Bravo capsule)
• Legal basis : FDA 21 CFR framework, Parts 806 and 803; the recall notices cite no specific provision
• Official source : FDA recall notice, ICU Medical (newest)

What was recalled

The pattern

The 13 product lines span four distinct contamination mechanisms with no common root cause proven. C.R. Bard received complaints of surface contamination on Pericare wipes supplied with six Foley and catheter trays. ICU Medical IV set drip chambers may contain black specks from discolored polyvinyl chloride left by the molding process, with particulate matter in the fluid path not ruled out. AVID Medical Halyard IV start kits contain ChloraPrep and FREPP applicators contaminated with Aspergillus penicillioides. Given Imaging Bravo CF capsules may fail to attach to the esophagus or detach from the delivery device, risking aspiration, esophageal perforation, and foreign bodies in the patient.

Twelve of the 13 recalled product lines originate in the United States; the Bravo CF capsule originates in Israel. All 13 are classified recall-ongoing. Two of the four events are serious, the AVID Medical Aspergillus contamination and the Given Imaging Bravo capsule attachment failure. The FDA enforces these recalls under its medical device authorities.

Who is exposed

US hospital distributors and group purchasing organizations sourcing IV sets and catheter trays, US importers of intravascular and urological devices, and the named brand owners are the exposed actors by US market exposure. ICU Medical, BD (Becton Dickinson, C.R. Bard Inc), AVID Medical, and Given Imaging Ltd. (Medtronic) supply these families into US hospitals and alternate-site channels. Distributors and GPOs hold the recalled lots; importers carry the customs and supply-chain documentation; manufacturers hold the batch records, test reports, and corrections-and-removals files.

What to check now

• Quarantine and pull recalled lots: match on-hand stock and listings against the FDA-recalled product lines, REF numbers, and lot identifiers.
• Review supplier test reports and batch records for particulate, microbial, and surface contamination, including PVC molding inspection for ICU Medical drip chambers.
• Verify ChloraPrep and FREPP applicator sterility for any AVID Medical Halyard IV start kits, given the Aspergillus penicillioides finding.
• Trace Bravo CF capsule lots back to Given Imaging and confirm attachment integrity before further clinical use.
• Confirm 21 CFR Part 806 corrections-and-removals documentation is complete for every recalled line returned or destroyed.
• File 21 CFR Part 803 medical device reports for any adverse events linked to the recalled lots, and document customer and consignee notifications.

Per-jurisdiction real-time monitoring of FDA enforcement data surfaces these waves the moment each notice publishes, so the supply chain can act before a recalled lot reaches a patient.

Sources

• FDA recall, ICU Medical IV Sets with drip chambers (Z-3163/2026)
• FDA recall, ICU Medical IV Sets with drip chambers (Z-3162/2026)
• FDA recall, ICU Medical IV Sets with drip chambers (Z-3161/2026)
• FDA recall, ICU Medical IV Sets with drip chambers (Z-3160/2026)
• FDA recall, ICU Medical Plum administration sets (Z-3156/2026)
• FDA recall, AVID Medical Halyard IV start kit (Z-3108/2026)
• FDA recall, C.R. Bard Foley Tray System Bardex IC, REF A3003 (Z-3119/2026)
• FDA recall, C.R. Bard SureStep Foley Tray Add-A-Foley, REF A153200 (Z-3118/2026)
• FDA recall, C.R. Bard SureStep Intermittent Catheter Tray (Z-3117/2026)
• FDA recall, C.R. Bard Bardex IC Complete Care Foley Tray, REF 300316A (Z-3116/2026)
• FDA recall, C.R. Bard Bard Foley Tray, Lubri-Sil Foley Catheter (Z-3115/2026)
• FDA recall, C.R. Bard Bardex Lubricath Foley Catheter Tray (Z-3114/2026)
• FDA recall, Given Imaging Bravo CF capsule delivery device (Z-3090/2026)
• 21 CFR Part 806, Corrections and Removals
• 21 CFR Part 803, Medical Device Reporting