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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 1901–1920 of 39,430 recalls

Class IIOngoing

Burette 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. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.

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 15D, 2 CARESITES, 153 IN.; Catalog Number: 490542.

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. NF1500UP, IV ADMINISTRATION SET; Catalog Number: 490070.

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, 15 DROPS/ML 125 IN; Catalog Number: 490452.

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 W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457506.

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. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520.

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, 81 IN W/ 32 IN EXT SET; Catalog Number: 490329.

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. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.

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 115 in.; Catalog Number: 490354.

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

ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.

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

Caresite 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. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.

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

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Philips North America Llc

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

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 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

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

Caresite 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 numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

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

Blood 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. Y-TYPE BLOOD SET W/ 170¿M FILTER; Catalog Number: 480233.

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, 15D, 144 IN.; Catalog Number: 490472.

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 W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.

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

SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.

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 AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301.

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. AS152V2DLL; Catalog Number: 473309.

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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