Class IOngoingZ-0591-2026
Draeger, Inc. recalls ErgoStar CM 45
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Recalls in Pennsylvania
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 181–192 of 581 recalls
Class IOngoingZ-0590-2026
Draeger, Inc. recalls ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of r…
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Class IIOngoingZ-0879-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Fusion
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0878-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0877-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Revelation
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0718-2026
B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administratio…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0717-2026
B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administratio…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0716-2026
B Braun Medical Inc recalls Outlook set utilized in gravity IV administration sets and pump administration sets uti…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0715-2026
B Braun Medical Inc recalls Vista set utilized in gravity IV administration sets and pump administration sets utili…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0714-2026
B Braun Medical Inc recalls ULTRASITE set utilized in gravity IV administration sets and pump administration sets u…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0713-2026
B Braun Medical Inc recalls SAFELINE set utilized in gravity IV administration sets and pump administration sets ut…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0712-2026
B Braun Medical Inc recalls SafeDAY set utilized in gravity IV administration sets and pump administration sets uti…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025