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

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

Z-2214-2026 · initiated April 21, 2026

Sourced

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98786

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

Z-2306-2026 · initiated April 21, 2026

Sourced

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98917

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

Z-2222-2026 · initiated April 21, 2026

Sourced

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98786

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;

Z-2373-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

Z-2367-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

Z-2368-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

Z-2369-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

Z-2396-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

Z-2366-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM

Z-2382-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2

Z-2375-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

Z-2380-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A

Z-2378-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

Z-2365-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;

Z-2393-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

Z-2390-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

Z-2376-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

Z-2364-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

Z-2391-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

Review official root-cause evidence and provenance

Official device-enrichment wording

Device enforcement product

Description/REF: ACCESS TRAY/ASK-04001-MC3

Z-2392-2026 · initiated April 21, 2026

Sourced

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 98793

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