Carefusion 2200 Inc

Carefusion 2200 Inc: 110 FDA recall reports

Every medical device recall the FDA has published for Carefusion 2200 Inc. The fault, and how the agency graded it.

110Reports
4Class I
79Ongoing
2023-08-23Most recent
4 Class I on this page

Class 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.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

ClassReports
Class II106
Class I4

By year reported

YearReports
20123
20132
20141
20163
20186
202015
202263
202317
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.

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgic

Z-2421-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Where it went
US and Canada
How much
2 units

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surg

Z-2420-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Where it went
US and Canada
How much
0 units

Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90

Z-2428-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Where it went
US and Canada
How much
1 unit

Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscop

Z-2417-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Where it went
US and Canada
How much
1 unit

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endos

Z-2418-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Where it went
US and Canada
How much
0 units

Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surg

Z-2415-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Where it went
US and Canada
How much
3 units

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgic

Z-2422-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Where it went
US and Canada
How much
4 units

Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surg

Z-2423-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Where it went
US and Canada
How much
0 units

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surg

Z-2427-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Where it went
US and Canada
How much
7 units

Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic

Z-2416-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Where it went
US and Canada
How much
3 units

Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP9

Z-2424-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Where it went
US and Canada
How much
1 unit

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgi

Z-2419-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Where it went
US and Canada
How much
8 units

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgica

Z-2425-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Where it went
US and Canada
How much
42 units

Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopi

Z-2426-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
Where it went
US and Canada
How much
0 units

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgica

Z-2429-2023  ·  Class II  ·  reported 2023-08-23  ·  Ongoing

Why it was recalled
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Where it went
US and Canada
How much
20 units

(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and

Z-1421-2023  ·  Class II  ·  reported 2023-05-03  ·  Ongoing

Why it was recalled
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
Product
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
Where it went
Distribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WV, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Canada.
How much
726 units

CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. C

Z-1236-2023  ·  Class II  ·  reported 2023-03-15  ·  Ongoing

Why it was recalled
Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
Product
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN; 9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE; 10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED; 11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK; 12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE; 13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD; 14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN; 15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE; 16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED; 17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK; 18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE; 19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD; 20....
Where it went
Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United Arab Emirates.
How much
5,952 devices

Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), RE

Z-0391-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
1810 units

Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112

Z-0382-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
100 units

Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM)

Z-0377-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
84 units

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM

Z-0411-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
5 units

CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVE

Z-0415-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
142 units

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225M

Z-0410-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
28 units

Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM

Z-0393-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
27 units

Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010

Z-0394-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
1063 units

CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2"

Z-0397-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
2 unist

Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4"

Z-0387-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
17 units

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061

Z-0404-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
35 units

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM)

Z-0409-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
45 units

CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF

Z-0374-2023  ·  Class II  ·  reported 2022-12-14  ·  Ongoing

Why it was recalled
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Product
CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
Where it went
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
How much
418 units

Showing the 30 most recent of 110. 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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