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 19, 2026 02:15
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
32,075 recalled products
12,273 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: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Review official root-cause evidence and provenance
Official device-enrichment wording
Labeling mix-ups
Device enforcement product
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
Review official root-cause evidence and provenance
Official device-enrichment wording
Device Design
Device enforcement product
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
Device enforcement product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Review official root-cause evidence and provenance
Official device-enrichment wording
Process control
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
