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

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

CRE Wireguided 8-10mm 240cm

Z-2633-2026 · initiated May 21, 2026

Sourced

Recalling firm: Boston Scientific Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99067

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.

Z-2657-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710

Z-2540-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

CRE Pro Wireguided 12-15mm 240cm

Z-2629-2026 · initiated May 21, 2026

Sourced

Recalling firm: Boston Scientific Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99067

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I

Z-2539-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Z-2667-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Z-2659-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; 12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980; 13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; 14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A; 15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A; 16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640; 17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B; 18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605; 19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330; 20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; 21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110; 22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A; 23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B; 24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC; 25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180; 27) NO CATH DIALYSIS KIT, Model Number: ECVC8595; 28) SOFT TISSUE TRAY, Model Number: DYNDA1954A; 30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A; 31) LACERATION TRAY, Model Number: SUT10520; 32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB; 33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B; 34) BIOPSY TRAY, Model Number: MNS7065A; 35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85; 36) A LINE TRAY, Model Number: ART690; 37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490; 38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633; 39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A; 40) BIOPSY PACK, Model Number: DYNDH1135B; 41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; 42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485; 43) ULTRA SOUND TRAY, Model Number: CVI190; 44) BASIC BIOPSY TRAY, Model Number: SPEC0051; 45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB; 46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A; 47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; 48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406; 49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632; 50) I & D KIT, Model Number: ID1135A; 51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637; 52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080; 53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; 54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331; 55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA; 56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B; 57) A LINE KIT, 20G, Model Number: ART1303; 58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; 59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C; 60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616; 61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A; 62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B; 63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475; 64) CVC BUNDLE KIT, Model Number: ECVC1700; 65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C; 66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950; 67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360; 68) PLASTICS SUTURING SET, Model Number: SUT4065; 69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465; 70) ARTHROGRAM TRAY, M

Z-2541-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

Z-2656-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147

Z-2534-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

CRE Pro Wireguided 10-12mm 240cm

Z-2628-2026 · initiated May 21, 2026

Sourced

Recalling firm: Boston Scientific Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99067

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C

Z-2538-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265

Z-2542-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Z-2661-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ARTIS icono ceiling. Model Number: 11328100.

Z-2642-2026 · initiated May 20, 2026

Sourced

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99079

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).

Z-2605-2026 · initiated May 20, 2026

Sourced

Recalling firm: Insulet Corporation
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99034

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ARTIS icono floor. Model Number: 11327700.

Z-2643-2026 · initiated May 20, 2026

Sourced

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99079

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

ARTIS icono biplane. Model Number: 11327600.

Z-2641-2026 · initiated May 20, 2026

Sourced

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99079

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).

Z-2604-2026 · initiated May 20, 2026

Sourced

Recalling firm: Insulet Corporation
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99034

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).

Z-2603-2026 · initiated May 20, 2026

Sourced

Recalling firm: Insulet Corporation
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99034

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