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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1941–1960 of 39,430 recalls

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 138 IN.; Catalog Number: 490426.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124 IN.; Catalog Number: 470005.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.; Catalog Number: 490451.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 125 IN.; Catalog Number: 490487.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490400.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCKS, 124 IN; Catalog Number: 490476.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET ULTRAPORT STOPCOCK, 37IN.; Catalog Number: 490234.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML, 134 in.; Catalog Number: 490357.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH 15 DROPS/ML; Catalog Number: 490507.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Medicrea International

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN. EXT SET 9 IN.; Catalog Number: 490317.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET, 25 IN.; Catalog Number: 490629.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT SET; Catalog Number: 490467.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS, 162 IN.; Catalog Number: 490484.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

Class IIOngoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML 124 IN.; Catalog Number: 490427.

B Braun Medical Inc

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

October 29, 2025 · DeviceView details →

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