Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Teleflex medical devices: approvals, recalls and adverse events

Stock: TFX. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

241

De Novo: 1

PMA approvals

45 supplements

Recalled products

1,229

298 class I

Adverse event reports

72K

549 deaths reported

How many recalls does Teleflex have?

Teleflex has 1,229 recalled medical device products in 298 recall actions in the records, 298 of them class I (the most serious kind). The newest recall started on May 7, 2026. In 2024 it had 5 recalled products.

How many medical devices has Teleflex had cleared or approved?

241 510(k) clearances, 1 De Novo grants and 2 original PMA approvals for high-risk devices, plus 45 PMA supplements (changes to approved devices). The newest decision was on Aug 5, 2026.

How many adverse event reports name Teleflex devices?

72,114 reports in total: 549 deaths, 6,170 injuries and 65,070 malfunctions were reported. 5,098 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	5	0	0	2
2025	6	0	0	2
2024	5	0	0	2
2023

Newest clearances and approvals

Rusch Latex Gold Foley Catheter
K262056 · 510(k) clearance · Aug 5, 2026
Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
K261988 · 510(k) clearance · Jul 9, 2026
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
K252643 · 510(k) clearance · May 15, 2026
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
K260775 · 510(k) clearance · May 6, 2026
Rusch SoftSimplastic Foley Catheters
K252537 · 510(k) clearance · Jan 20, 2026
Hem-o-lok PurplePlus Large Polymer Ligating Clips
K251054 · 510(k) clearance · Jul 3, 2025
LMA Fastrach ETT SU
K242495 · 510(k) clearance · Apr 29, 2025
AC3 Range Intra-Aortic Balloon Pump
K250542 · 510(k) clearance · Mar 26, 2025
QuikClot Control+ Hemostatic Device
K243553 · 510(k) clearance · Mar 18, 2025
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · 510(k) clearance · Mar 14, 2025
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

Devices with the most adverse event reports

By product code, all years

System, Balloon, Intra-Aortic And Control (DSP, class 2)9,144
Catheter, Percutaneous (DQY, class 2)7,942
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ, class 2)5,901
Clip, Implantable (FZP, class 2)4,437
Stapler, Skin (QQS, class 1)3,768
Tube, Tracheal (W/Wo Connector) (BTR, class 2)3,275
Staple, Removable (Skin) (GDT, class 1)2,739
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (LJS, class 2)2,364
Applier, Surgical, Clip (GDO, class 1)1,895

All device makers and procedures · TFX stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to TFX with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	48	39	3,442	7
2025	0	0	5,098	7
2024	5	4	5,779	20
2023	135	128	5,545	22
2022	56	46	4,450	22
2021	16	4	3,986	20
2020	84	15	4,172	38
2019	107	22	6,227	32
2018	122	0	4,438	16
2017	163	1	4,635	24
2016	49	14	4,364	29
2015	40	6	3,448	19
2014	104	17	2,736	15
2013	15	1	2,304	8
2012	10	1	1,909	14

Newest recalls

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (Cotton) Model/Catalog
Class II · May 7, 2026 · Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: ACCESS TRAY/ASK-04001-MC3
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFT
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Class I · Apr 21, 2026 · Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss