Recall events
/
Event 90946
Event summary
Timeline bucket September 30, 2022
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording MEDLINE INDUSTRIES, LP - Northfield
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
13 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 13
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Z-0155-2023
Recall number Z-0155-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 95 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0155-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17002]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40195327061327, Lot Number 22DBM504
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[34929]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 13
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Z-0156-2023
Recall number Z-0156-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 160 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0156-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39875]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40193489234405, Lot Number 22DBM505
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[35330]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 13
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Z-0157-2023
Recall number Z-0157-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 800 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0157-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33679]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 10889942336241, Lot Number 22DBN365
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[33561]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 13
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
Z-0158-2023
Recall number Z-0158-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 300 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0158-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52224]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40193489577540, Lot Number 22DBN862
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[33603]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 13
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Z-0159-2023
Recall number Z-0159-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 16 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0159-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52226]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (010 10889942352920, Lot Number 22DBN366
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[35917]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 13
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Z-0160-2023
Recall number Z-0160-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 28 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0160-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45506]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 10889942339730, Lot Number 22DBM506
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36382]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 13
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Z-0161-2023
Recall number Z-0161-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 708 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0161-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21846]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 10195327108168, Lot Number 22DBL466
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36386]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 13
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Z-0162-2023
Recall number Z-0162-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 96 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0162-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45509]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 4019532701228, Lot Number 22DBL482
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[35494]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 13
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
Z-0163-2023
Recall number Z-0163-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 40 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0163-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27939]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40195327002535, Lot Number 22DBJ856
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36398]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0164-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 60 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0164-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33678]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40193489385404, Lot Number 22DBE139
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36131]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0165-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 240 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0165-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9612]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 10195327027278, Lot Number 22OBK037
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36375]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0166-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 50 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0166-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52225]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information UDI/DI (01) 40195327045471, Lot Number 22ABT774
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36138]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0167-2023
Initiated September 30, 2022
Classification Class II
Status Ongoing
Quantity 50 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0167-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58658]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information GTIN (01) 40653160316252, Lot Number 21KBB343
Distribution pattern US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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[36119]
FDA event record
· Exact recall-number query on openFDA
