B. Braun Medical, Inc.: 401 FDA recall reports
Every medical device recall the FDA has published for B. Braun Medical, Inc.. The fault, and how the agency graded it.
401Reports
24Class I
223Ongoing
2026-06-10Most recent
24 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software
Z-2266-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 690
Class I
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in.
Z-2277-2026 · Class I · reported 2026-06-10 · Ongoing
- Why it was recalled
- These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
- Product
- Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
- Where it went
- US Nationwide distribution.
- How much
- 16,080 units
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076
Z-2263-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 280
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 5558
Z-2269-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 680
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number
Z-2265-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 1730
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software
Z-2264-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 210
Class I
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPR
Z-2276-2026 · Class I · reported 2026-06-10 · Ongoing
- Why it was recalled
- These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
- Product
- Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)
- Where it went
- US Nationwide distribution.
- How much
- 582,030 units
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number:
Z-2267-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 620
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 S
Z-2268-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 690
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134
Z-2270-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No
- Where it went
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- How much
- 390
Class I
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number):
Z-2278-2026 · Class I · reported 2026-06-10 · Ongoing
- Why it was recalled
- These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
- Product
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
- Where it went
- US Nationwide distribution.
- How much
- 104,720 units
Class I
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Z-1801-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 328,640 units
Class I
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Z-1798-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 3,158,104 units
Class I
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Z-1800-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 1,174,271 units
Class I
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Z-1803-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 4,884 units
Class I
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Z-1802-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 4,848 units
Class I
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Z-1799-2026 · Class I · reported 2026-04-22 · Ongoing
- Why it was recalled
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 2,653,711 units
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A
Z-1483-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Product
- Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- How much
- 51300 units
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Ve
Z-1482-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Product
- Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- How much
- 21000 units
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Softwa
Z-1481-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Product
- Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- How much
- 105550 units
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with
Z-0617-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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 120 IN; Catalog Number: 490355.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 24,624 units
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BB
Z-0656-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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 126 IN; Catalog Number: 490283.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 65,904 units
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with
Z-0616-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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 124 IN.; Catalog Number: 490196.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 7,344 units
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
Z-0712-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- SafeDAY 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 ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 554,015 units
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BB
Z-0647-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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 15D, 2 B/C VLV, 3 CARESITE LADS; Catalog Number: 490653.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 48 units
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's
Z-0607-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 104,784 units
Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusom
Z-0640-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431. 8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432. 9. 60...
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 49,330,370
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Inf
Z-0639-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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/2INJ/FLBL/FML LRLK/CV 34; Catalog Number: V5405.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 300 units
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BB
Z-0679-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 15,250 units
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BB
Z-0705-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Product
- 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. AESTHESIA IV SET, 127 in.; Catalog Number: 490551.
- Where it went
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- How much
- 4,488 units
Showing the 30 most recent of 401. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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