Class IIOngoingZ-2963-2026
Maquet Critical Care AB recalls GETINGE Y SENSOR Module
The module did not undergo electrical safety tests and functional tests during production.
Maquet Critical Care A…Aug 26, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 121–132 of 674 recalls
Class IIOngoingZ-2962-2026
Boston Scientific Corporation recalls Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2961-2026
Boston Scientific Corporation recalls OverStitch Suture Cinch
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2950-2026
Covidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 1088452180930…
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Covidien, LLCCAAug 26, 2026
Class IIOngoingZ-2936-2026
BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based…
Due to increase in false negative results
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Under Investigation by firm
BioFire Diagnostics, L…UTAug 19, 2026
Class IIOngoingZ-2935-2026
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Straumann USA LLCMAAug 19, 2026
Class IIOngoingZ-2930-2026
Terumo Medical Corporation recalls GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. Th…
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Terumo Medical Corpora…MDAug 19, 2026
Class IIOngoingZ-2929-2026
Straumann USA LLC recalls GM Helix Implant
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.…
Straumann USA LLCMAAug 19, 2026
Class IIOngoingZ-2927-2026
Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Remel Europe Ltd.Aug 19, 2026
Class IIOngoingZ-2926-2026
Medline Industries, LP recalls Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Medline Industries, LPILAug 19, 2026
Class IIOngoingZ-2925-2026
Medline Industries, LP recalls Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Medline Industries, LPILAug 19, 2026
Class IIOngoingZ-2924-2026
Medline Industries, LP recalls Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Medline Industries, LPILAug 19, 2026