Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Mar 15, 2023
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DiaSorin Molecular LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Inc.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LetsGetChecked Inc.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Linet Spol. S.r.o.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Preat Corp.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sensus Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Ultracell Wick with 80cc Collection Bag, 20/box
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health, Inc.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coltene Whaledent Inc.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Mar 8, 2023
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Med-Riser MR600 Patient Lift
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Med-Mizer, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Phoenix mKDR, digital mobile diagnostic x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.