Recall events
/
Event 88250
Event summary
Timeline bucket May 28, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Covidien, LP
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
18 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Z-2358-2021
Recall number Z-2358-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2358-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28473]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32923]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Z-2359-2021
Recall number Z-2359-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2359-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15213]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34487]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Z-2360-2021
Recall number Z-2360-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2360-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33553]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1726500092 1806600073 1833800146 2009200089 1728600060 1815800078 1904900089 2012100138 1733300161 1816400084 1906300059 2020400105 1733700172 1826200176 1910200093 2026000059 1733700178 1826800155 1917600105 2027200241 1800300143 1828200124 1926100255 2028200207 1804000125 1831000115 1931600120 2028200207 1804500144 1832300108 2000700070
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34497]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Z-2361-2021
Recall number Z-2361-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2361-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11425]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1800300145 1814300204 2009300078 2027200251 1805900115 1926100256 2017500135
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34478]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
Z-2362-2021
Recall number Z-2362-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2362-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11422]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1815000193 1920500218 2014900146 2012100124 1905600053
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34792]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 18
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Z-2363-2021
Recall number Z-2363-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2363-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4625]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1725600159 1831000117 1906000012 1910600263 1732700137 1902800146 1908400348 2009300117
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34621]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 18
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Z-2364-2021
Recall number Z-2364-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2364-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28469]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1708800198 1714400174 1904900098 2009300086
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35221]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 18
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Z-2365-2021
Recall number Z-2365-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2365-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4622]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1616800188 1719300113 1828900138 2023300147 1703200130 1816400079 1833800127 2026000048 1713700156 1822000123 2009300120
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35124]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 18
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Z-2366-2021
Recall number Z-2366-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2366-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22544]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1834500202 1920500219 2014900143 2020400107 1914800210 2009300121 2017500133 2023300110
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32968]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2367-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2367-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58156]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1705400292
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33250]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2368-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2368-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33554]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1704700210 1822600138 1826200177
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32941]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2369-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2369-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28472]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1925300162
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34467]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2370-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2370-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33550]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34482]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2371-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2371-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15212]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1724200116 1815000199 1921300032 1932300191 1725600107 1815800076 1921300034 1932300192 1727100076 1817100090 1927500067 2023300141 1728600062 1817700206 1929400086 2027200174 1734700104 1826800141 1929500067 2026000073 1801000128 1831600197 1929500068 2028200214 1802400119 1833100112 1929500071 2028200215 1804000126 1905600140 1929500088 2033100065 1805200078 1906000165 1929500089 2032800041 1806600074 1908400286 1929500072 2034400102 1807300167 1906700185 1930900073 1808600066 1920500223 1930900074
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32925]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2372-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2372-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11426]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 2034400130 1812200184 1911500092 2000700096 2034400084 1816400076 1914800226 2004400083 1724900107 1818500196 1924000133 2014900152 1731200157 1819100094 1926100267 2019500164 1731900150 1826200149 1926100246 2027200171 1801000137 1903500128 1927300072 2028200206 1802400068 1908800158 1930900080 2034400084 1810400148 1907800094 1930900081 2034400130
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32927]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2373-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2373-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40355]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1727100082 1804000124 1908400303 2001400121 1730500134 1805900129 1926100248 2009300116 1732700146 1816400078 1926100292 2023300132 1734700118 1823400098 1931600117 2027200192 1801000131 1902800150
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32920]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2374-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2374-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33552]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1729700119 1817700205 1910600266 2014900148 1810400147 1828900137 2014900151 2034400131
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32918]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2375-2021
Initiated May 28, 2021
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2375-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45261]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code information Lot Numbers: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33269]
FDA event record
· Exact recall-number query on openFDA
