Recall events
/
Event 69842
Event summary
Timeline bucket November 21, 2014
Product types Device
Classifications Class II
Statuses Completed
Recalling firm wording Smiths Medical ASD, 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
3 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 3
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Z-0897-2015
Recall number Z-0897-2015
Initiated November 21, 2014
Classification Class II
Status Completed
Quantity 334,000
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Needle is not captured in the needle safety sheath in specific lots.
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-0897-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[49719]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Needle is not captured in the needle safety sheath in specific lots.
Code information Lot Numbers: 2731779, 2763138, 2771516, 2771517
Distribution pattern US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
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[23306]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Z-0898-2015
Recall number Z-0898-2015
Initiated November 21, 2014
Classification Class II
Status Completed
Quantity 47,200
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Needle is not captured in the needle safety sheath in specific lots.
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-0898-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55777]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Needle is not captured in the needle safety sheath in specific lots.
Code information Lot Numbers: 2756526, 2771498
Distribution pattern US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
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[17406]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Z-0899-2015
Recall number Z-0899-2015
Initiated November 21, 2014
Classification Class II
Status Completed
Quantity 10,000
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Needle is not captured in the needle safety sheath in specific lots.
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-0899-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31893]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Needle is not captured in the needle safety sheath in specific lots.
Code information Lot Number: 2755713
Distribution pattern US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
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[17503]
FDA event record
· Exact recall-number query on openFDA
