FDA Enforcement · Jul 15, 2026
Device recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A product error defect may cause incorrect bracket placement. — Klowen Braces · Class II · Ongoing · 3 units
Latest medical news · page 67
The latest headlines across every section, pulled from official and open-access sources.
FDA Enforcement · Jul 15, 2026
Device recall: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or … — Medtronic MiniMed, Inc. · Class II · Ongoing · 778
FDA Enforcement · Jul 15, 2026
Device recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. — Olympus Corporation of the Americas · Class II · Ongoing · 988700 units
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number:…
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. — CMR SURGICAL LIMITED · Class II · Ongoing · 2
FDA Enforcement · Jul 15, 2026
Device recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 1400 kits
FDA Enforcement · Jul 15, 2026
Device recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. — Siemens Healthcare Diagnostics, Inc. · Class II · Ongoing · 24,077 units
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 1
FDA Enforcement · Jul 15, 2026
Device recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD…
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. — Fresenius Medical Care Holdings, Inc. · Class II · Ongoing · 113,544 units (4,731 cases)
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description:…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 586
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 1317
FDA Enforcement · Jul 15, 2026
Device recall: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004…
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. — Think Surgical, Inc. · Class II · Ongoing · 360 devices
FDA Enforcement · Jul 15, 2026
Device recall: VITEK 2 AST-N447 TEST KIT Product reference 424620
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. — Biomerieux Inc · Class II · Ongoing · 45,900 cards
FDA Enforcement · Jul 15, 2026
Device recall: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT…
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. — Boston Scientific Neuromodulation Corporation · Class II · Ongoing · 37,764
FDA Enforcement · Jul 15, 2026
Device recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model…
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 396 kits
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703…
Due to packaging discrepancy with incorrect product size mixed up. — Encore Medical, LP · Class II · Ongoing · 4
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711…
Due to packaging discrepancy with incorrect product size mixed up. — Encore Medical, LP · Class II · Ongoing · 8
FDA Enforcement · Jul 15, 2026
Device recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model…
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 75 kits
FDA Enforcement · Jul 15, 2026
Device recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. — Integra LifeSciences Corp. (NeuroSciences) · Class II · Ongoing · 633 units
FDA Enforcement · Jul 15, 2026
Food recall: Smoked Sausage Spice 32.86#
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 120 units
FDA Enforcement · Jul 15, 2026
Food recall: Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073…
undeclared soy — Bear Stewart Co · Class II · Ongoing · 313 cases
FDA Enforcement · Jul 15, 2026
Food recall: EC Hot Links Seasoning 45.05#
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 81 units
FDA Enforcement · Jul 15, 2026
Food recall: Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3. — Wise Foods Inc · Class II · Ongoing · 490 cases
FDA Enforcement · Jul 15, 2026
Food recall: Trafa Pharmaceuticals Inc. brand ORGANIC MORINGA LEAF POWDER; NET WEIGHT: 15 KGS
Potential contamination with Salmonella — Trafa Pharmaceutical Inc. · Class I · Ongoing · 500 kg
FDA Enforcement · Jul 15, 2026
Food recall: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams.…
Undeclared Allergen (Soy) — Specialty Bakers, LLC · Class II · Ongoing · 449 cases