Manufacturer

Pfm Medical Inc

10 recalls in our database name Pfm Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total: 10
Critical: 0
Severe: 1
Most recent: 2026-07-01

Of the 10 recalls from Pfm Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

ModerateFDA (Devices)·Z-2526-2026·2026-07-01
Multi-Snare Set catheter fails biocompatibility requirements
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0562-2015·2014-12-17
PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.
Product
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2015·2014-12-17
Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.
Product
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0563-2015·2014-12-17
PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits
PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.
Product
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2015·2014-12-17
PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin
PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.
Product
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2015·2014-12-17
PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays
PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they may exceed USP limits for bacterial endotoxin.
Product
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2015·2014-12-17
Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin
Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 units distributed in the US and abroad.
Product
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0564-2015·2014-12-17
PFM Medical Recalls Dual Lumen CT PICC Catheters for Bacterial Endotoxin
PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters because they may exceed USP limits for bacterial endotoxin.
Product
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0568-2015·2014-12-17
PFM Medical Recalls ASEPT Drainage Bags Due to Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 2000 ml Drainage Bags because they may exceed USP limits for bacterial endotoxin. The recall affects 370 units distributed in the US and internationally.
Product
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2015·2014-12-17
Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.
Product
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

pfm medical (Germany)

company in Cologne, Germany

Country: Germany
Founded: 2009

Official website

Source: Wikidata (Q50035547), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.