Device recall: B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other…
Class II FDA enforcement event 87074. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Aomori Olympus Co., Ltd. started this device recall on 4 Jan 2021. The firm address in the FDA record is in Kuroishi. FDA put the recall in Class II. FDA event 87074 has 111 product records. The first FDA enforcement report date is 17 Feb 2021. The record gives the status Terminated, with the termination date 11 Mar 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution.
Recalling firm
Aomori Olympus Co., Ltd., Kuroishi, N/A, Japan.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
111 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0961-2021 | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0962-2021 | B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0963-2021 | B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0964-2021 | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0965-2021 | B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0966-2021 | B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0967-2021 | B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0968-2021 | B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0969-2021 | PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0970-2021 | K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0971-2021 | K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0972-2021 | K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0973-2021 | K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0974-2021 | KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0975-2021 | KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0976-2021 | KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0977-2021 | KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0978-2021 | KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0979-2021 | KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0980-2021 | KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0981-2021 | KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0982-2021 | KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0983-2021 | KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0984-2021 | SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0985-2021 | SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (global); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0986-2021 | SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0987-2021 | SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0988-2021 | SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0989-2021 | SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0990-2021 | SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0991-2021 | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0992-2021 | SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0993-2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0994-2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0995-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0996-2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0997-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0998-2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-0999-2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1000-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1001-2021 | INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1002-2021 | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1003-2021 | INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1004-2021 | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1005-2021 | INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1006-2021 | INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1007-2021 | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1008-2021 | INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1009-2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1010-2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1011-2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1012-2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1013-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1014-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1015-2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1016-2021 | INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1017-2021 | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1018-2021 | INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1019-2021 | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
| Z-1020-2021 | INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. | 7,400,000 (globally); 260,395 (US) | Class II | Terminated | 17 Feb 2021 |
The table shows 60 of 111 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 111Median of the firm: 111
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jul 2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. D | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0961-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 87074. https://recallregister.com/fda/ii/87074/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution.
- What quantity of product is in FDA event 87074?
- The event has 111 product records. The first record gives this quantity:
7,400,000 (global); 260,395 (US)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.