BD PhaSeal Optima 515062Recalls & reported problems

BD Switzerland Sàrl · Protector (P13-O Multi) · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Jun 16, 2025Open, Classified
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Z-2453-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

Device details

UDI-DI	`00382905150623`
Brand	BD PhaSeal Optima
Model	515062
Company	BD Switzerland Sàrl
Product code	ONB · Closed antineoplastic and hazardous drug reconstitution and transfer system
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 17, 2025

Device type (GMDN): Vial/bottle adaptor, hermetic

A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.

Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices

BD PhaSeal 515003
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall183 reports
BD PhaSeal 515056
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall159 reports
BD PhaSeal Optima 515070
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall154 reports
Alaris 10012241-0500
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall138 reports
BD PhaSeal 515005
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall128 reports
ICU Medical CL3011
Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
3 recalls26 reports
BD PhaSeal Optima 515052
BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
1 recall114 reports
ICU Medical CL3511
Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
3 recalls6 reports

All Closed antineoplastic and hazardous drug reconstitution and transfer system devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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