Official device enrichment

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.

Inspect corpus status

Exact official wording

Root-cause wording register

40 distinct wordings

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

39,519 recalled products

14,800 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

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B; Part Number: 151730418. 6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B; Part Number: 151730420. 7. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 22mm B; Part Number: 151730422. 8. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 24mm B; Part Number: 151730424. 9. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 26mm B; Part Number: 151730426. 10. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 8mm B; Part Number: 151730408. 11. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 10mm C; Part Number: 151730510. 12. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 12mm C; Part Number: 151730512. 13. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 14mm C; Part Number: 151730514. 14. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 16mm C; Part Number: 151730516. 15. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 18mm C; Part Number: 151730518. 16. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 20mm C; Part Number: 151730520. 17. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 22mm C; Part Number: 151730522. 18. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 24mm C; Part Number: 151730524. 19. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 26mm C; Part Number: 151730526. 20. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 8mm C; Part Number: 151730508. 21. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 10mm E; Part Number: 151730710. 22. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 12mm E; Part Number: 151730712. 23. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 14mm E; Part Number: 151730714. 24. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 16mm E; Part Number: 151730716. 25. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 18mm E; Part Number: 151730718. 26. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 20mm E; Part Number: 151730720. 27. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 22mm E; Part Number: 151730722. 28. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 24mm E; Part Number: 151730724. 29. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 26mm E; Part Number: 151730726. 30. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 8mm E; Part Number: 151730708. 31. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 10mm W; Part Number: 151730810. 32. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 12mm W; Part Number: 151730812. 33. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 14mm W; Part Number: 151730814. 34. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 16mm W; Part Number: 151730816. 35. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 18mm W; Part Number: 151730818. 36. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 20mm W; Part Number: 151730820. 37. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 22mm W; Part Number: 151730822. 38. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 8mm F; Part Number: 151730808. 39. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 24mm W; Part Number: 151730824. 40. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 26mm W; Part Number: 151730826.

Z-2617-2026 · initiated May 19, 2026

Unknown

Recalling firm: DEPUY (IRELAND)
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99078

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

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.

Z-2411-2026 · initiated May 18, 2026

Sourced

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99223

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Z-2305-2026 · initiated May 18, 2026

Unknown

Recalling firm: DeRoyal Industries Inc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99044

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

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.

Z-2412-2026 · initiated May 18, 2026

Sourced

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99223

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Z-2457-2026 · initiated May 18, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98946

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

HarmonyAIR A-Series Surgical Lighting System

Z-2448-2026 · initiated May 15, 2026

Sourced

Recalling firm: Steris Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98767

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ALYON Surgical Lighting System

Z-2450-2026 · initiated May 15, 2026

Sourced

Recalling firm: Steris Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98768

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

HarmonyAIR A-Series Surgical Lighting System

Z-2449-2026 · initiated May 15, 2026

Sourced

Recalling firm: Steris Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98768

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.

Z-2615-2026 · initiated May 15, 2026

Unknown

Recalling firm: Medline Industries, LP
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99122

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

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2469-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Z-2360-2026 · initiated May 14, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98853

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

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2468-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2467-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2466-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2474-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2470-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2465-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2472-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy

Z-2464-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Z-2471-2026 · initiated May 14, 2026

Sourced

Recalling firm: ConMed Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98854

Review official root-cause evidence and provenance

Official device-enrichment wording

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