Recall events
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Event 89753
Event summary
Timeline bucket March 08, 2022
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Boston Scientific Corporation
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
2 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 2
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Z-0915-2022
Recall number Z-0915-2022
Initiated March 08, 2022
Classification Class II
Status Ongoing
Quantity 433 5-packs
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
seals may be open, compromising sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0915-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22573]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Pouch seals may be open, compromising sterility.
Code information ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
Distribution pattern Distribution in the US and territories, Japan, and Canada
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[34892]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Z-0916-2022
Recall number Z-0916-2022
Initiated March 08, 2022
Classification Class II
Status Ongoing
Quantity 488 5-packs
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
seals may be open, compromising sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0916-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22572]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Pouch seals may be open, compromising sterility.
Code information ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231
Distribution pattern Distribution in the US and territories, Japan, and Canada
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[35332]
FDA event record
· Exact recall-number query on openFDA
