Device recall enforcement reports
The weekly enforcement reports for device recalls, with the recall class. 39,969 records; openFDA updated it 2026-09-25. About this dataset
Newest records
- Class II35,307
- Class I3,632
- Class III1,029
- Not Yet Classified1
- MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels
- Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532…
Lutronic Corporation · Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in pati…
- Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 108017411…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(803…
Atrium Medical Corporation · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes:…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Mi…
HeartSine Technologies Ltd · Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
- Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 1080174…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Atrium Medical Corporation · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels
- Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 0…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging, Inc. · The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that hav…
- Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP…
Medical Action Industries, Inc. 306 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Halyard IV Start Kit Non-Sterile REF: KRIV26-02
AVID Medical, Inc. · Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding…
- Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Medical Action Industries, Inc. 306 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels
- Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
Given Imaging Ltd. · Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruct…
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741…
C.R. Bard Inc · Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(…
Atrium Medical Corporation · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.