Recall events
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Event 94793
Event summary
Timeline bucket June 12, 2024
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording Synergetics Inc
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
4 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 4
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Z-2251-2024
Recall number Z-2251-2024
Initiated June 12, 2024
Classification Class I
Status Ongoing
Quantity 14 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterilization certificates could not be validated by the supplier
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2251-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17279]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterilization certificates could not be validated by the supplier
Code information UDI/DI 20841305107544, Lot Number P62764979R
Distribution pattern US Nationwide
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[5344]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Z-2252-2024
Recall number Z-2252-2024
Initiated June 12, 2024
Classification Class I
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterilization certificates could not be validated by the supplier
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2252-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40211]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterilization certificates could not be validated by the supplier
Code information UDI/DI 20841305107551, Lot Number P63044983R
Distribution pattern US Nationwide
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[5122]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Z-2253-2024
Recall number Z-2253-2024
Initiated June 12, 2024
Classification Class I
Status Ongoing
Quantity 116 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterilization certificates could not be validated by the supplier
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2253-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5122]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterilization certificates could not be validated by the supplier
Code information UDI/DI 20841305107605, Lot Number P62764965R
Distribution pattern US Nationwide
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[5287]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Z-2254-2024
Recall number Z-2254-2024
Initiated June 12, 2024
Classification Class I
Status Ongoing
Quantity 35 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterilization certificates could not be validated by the supplier
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2254-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40212]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterilization certificates could not be validated by the supplier
Code information UDI/DI 20841305107612, Lot Number P62764970R
Distribution pattern US Nationwide
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[5208]
FDA event record
· Exact recall-number query on openFDA
