Separate sourced root-cause wording from missing evidence.
This laboratory joins device enforcement products to public FDA device-enrichment records through
documented exact identifiers. It preserves official wording and never turns an absent or conflicting join into a conclusion.
Four explicit evidence outcomes
What each state means
Global device-product counts
Sourced 32,075 products
At least one exact joined official device-enrichment row contains root-cause wording. The wording is preserved as an official fact, not an app conclusion.
? Unknown 7,441 products
An exact joined enrichment record exists, but none supplies supported root-cause wording. This does not mean FDA reported that the cause is unknown.
Unavailable 3 products
No public enrichment row could be joined through the supported exact identifiers, or the enrichment source itself was unavailable. This is not evidence of no root cause.
Ambiguous 0 products
Official identifier candidates conflict. Recall Observatory preserves the conflict and does not select a candidate or synthesize root-cause wording.
Coverage and provenance
Device sources represented
Device enrichment
openFDA Device Recall ·
event_date_initiated coverage
June 01, 1997–June 30, 2026
Official source
· published July 16, 2026 07:05
Enforcement
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.
Official source
· published July 16, 2026 07:03
Enforcement bounds use FDA report dates; device-enrichment bounds use FDA event_date_initiated. A product's recall-initiation date can precede enforcement report-date coverage.
Counts use distinct recalled products and exact recall events. Wording is grouped only by byte-for-byte database equality;
similar phrases are not normalized, merged, ranked, or interpreted as equivalent causes.
Exact official device root-cause wording counts
Official root-cause wording
Recalled products
Exact events
Device Design
5,544
2,055
Process control
4,983
1,836
Nonconforming Material/Component
4,049
1,363
Software design
2,469
1,529
Packaging
1,376
150
Component design/selection
1,096
440
Other
984
377
No Marketing Application
941
214
Packaging process control
846
256
Process change control
807
277
Error in labeling
790
298
Process design
790
322
Employee error
749
410
Package design/selection
636
117
Labeling design
631
223
Equipment maintenance
505
126
Labeling Change Control
485
268
Material/Component Contamination
423
165
Labeling mix-ups
401
260
Component change control
391
154
Use error
316
142
Mixed-up of materials/components
290
180
Radiation Control for Health and Safety Act
274
181
Storage
270
42
Vendor change control
258
66
Packaging change control
255
72
Labeling False and Misleading
253
116
Software Design Change
209
145
Environmental control
186
36
Software change control
159
89
Incorrect or no expiration date
144
59
Software Manufacturing/Software Deployment
137
84
Software design (manufacturing process)
100
62
Reprocessing Controls
88
28
Manufacturing material removal
82
21
Software in the Use Environment
82
60
Release of Material/Component prior to receiving test results
40
28
Finished device change control
26
15
PMA
6
3
Counterfeit
4
4
Current device enforcement corpus
7,441 recalled products
2,526 exact events
The selected filter changes this product ledger and its product/event summary only. The four-state overview and exact-wording register remain global corpus context.
Device enforcement product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Number: 151730016. 5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F; Part Number: 151730018. 6. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN G; Part Number: 151730020. 7. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN H; Part Number: 151730022. 8. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN I; Part Number: 151730024. 9. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN J; Part Number: 151730026. 10. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN K; Part Number: 151730028. 11. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN L; Part Number: 151730030. 12. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN M; Part Number: 151730032. 13. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN N; Part Number: 151730034. 14. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN P; Part Number: 151730038. 15. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN Q; Part Number: 151730040. 16. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN R; Part Number: 151730042. 17. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN S; Part Number: 151730044. 18. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN T; Part Number: 151730046. 19. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN U; Part Number: 151730048. 20. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN V; Part Number: 151730050. 21. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN W; Part Number: 151730052. 22. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN X; Part Number: 151730036.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Device enforcement product
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE¿ TAG¿ Conformable Thoracic Endoprosthesis to accommodate the intended treatment site.
Review official root-cause evidence and provenance
? Unknown
An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.
Evidence boundary: this page reports official device-enrichment wording and exact join outcomes.
It does not infer a root cause, merge similar phrases, or treat missing enrichment as evidence of no root cause.
Review the full methodology
