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Recall Observatory FDA recall evidence

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

Clear

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 15-18mm 240cm

Z-2636-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

Device enforcement product

Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device

Z-2550-2026 · initiated May 21, 2026

Sourced
Classification
Class I
FDA status
Ongoing
Evidence destination
Event 99119
Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

Z-2658-2026 · 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

Nonconforming Material/Component

Device enforcement product

CRE Pro Wireguided 15-18mm 240cm

Z-2630-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

Device enforcement product

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used.

Z-2664-2026 · 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

Nonconforming Material/Component

Device enforcement product

Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK

Z-2537-2026 · 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

Nonconforming Material/Component

Device enforcement product

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Z-2662-2026 · 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

Nonconforming Material/Component

Device enforcement product

CRE Pro Wireguided 6-8mm 240cm

Z-2626-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

Device enforcement product

CRE Wireguided 8-10mm 240cm

Z-2633-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

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

Nonconforming Material/Component

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

Nonconforming Material/Component

Device enforcement product

CRE Pro Wireguided 12-15mm 240cm

Z-2629-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

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

Nonconforming Material/Component

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

Nonconforming Material/Component

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

Nonconforming Material/Component

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

Nonconforming Material/Component

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

Nonconforming Material/Component

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

Nonconforming Material/Component

Device enforcement product

CRE Pro Wireguided 10-12mm 240cm

Z-2628-2026 · initiated May 21, 2026

Sourced
Classification
Class II
FDA status
Ongoing
Evidence destination
Event 99067
Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

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

Nonconforming Material/Component

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