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U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

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1026–1050 of 26417

HighFDA (Devices)·Z-1604-2026·2026-04-01
Orthopedic plates and screws recalled for MRI safety concerns
I.T.S. surgical plates and screws are recalled because updated testing found higher radiofrequency-induced heating during MRI than stated in original instructions.
Product
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1633-2026·2026-04-01
Straumann Custom Titanium Abutments Recalled for Incorrect Raw Material
Straumann USA recalled 7 Custom Abutment AS Ti units due to a manufacturing error in which a TAN material bar was incorrectly used instead of titanium.
Product
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1596-2026·2026-04-01
Orthopedic Surgical Plates Recalled Due to MRI Heating Concern
I.T.S. GmbH is recalling Pilonplate with Angular Stability orthopedic surgical plates due to MRI safety concerns. Updated testing shows higher radiofrequency-induced temperature increases during MRI than previously documented in the product's instructions.
Product
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 2109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2026·2026-04-01
Pelvic Reconstruction System implants recalled for MRI heating risk
I.T.S. GmbH is recalling Pelvic Reconstruction System implants because updated MRI safety testing revealed higher radiofrequency-induced temperatures than originally documented. This discrepancy between the devices' actual heat generation and the instructions could pose a burn risk during MRI procedures.
Product
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1650-2026·2026-04-01
Puracol and Puracol Plus Collagen Wound Dressings Recalled for Elevated Endotoxin Levels
Medline Industries is recalling Puracol and Puracol Plus Collagen Wound Dressings due to elevated endotoxin levels. Affected products may cause tissue irritation, delayed healing, or in severe cases, septic shock.
Product
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0405-2026·2026-04-01
Octreotide Acetate Injection Recalled Due to Sterility Assurance Quality Deficiency
Teva Pharmaceuticals is recalling 19,869 cartons of Octreotide Acetate injection due to quality system deficiencies at the manufacturer that affect sterility assurance. The FDA discovered these deficiencies during a routine inspection.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2026·2026-04-01
Octreotide Acetate Injectable Suspension Recalled for Sterility Assurance Deficiency
Teva Pharmaceuticals is recalling Octreotide Acetate injectable suspension (30 mg) nationwide due to quality system deficiencies at the contract manufacturer that compromised sterility assurance.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1605-2026·2026-04-01
FLS and HOL Foot Locking Plates Recalled for MRI Thermal Safety
I.T.S. GmbH is recalling FLS and HOL foot locking plates because updated MRI safety testing shows higher RF-induced temperature increases than previously documented. Patients with these implants should consult product instructions before undergoing MRI.
Product
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 373
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2026·2026-04-01
Olympus PKS Cutting Forceps recalled due to defective weld fracture risk
Olympus is recalling PKS Cutting Forceps worldwide due to defective welds in supplier components. The surgical instrument's jaw can break during clinical use.
Product
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0404-2026·2026-04-01
Octreotide Acetate Injectable Suspension Recalled for Sterility Assurance Deficiency
Teva Pharmaceuticals is recalling Octreotide Acetate injectable suspension nationwide due to quality system deficiencies identified at the contract manufacturer that affect assurance of product sterility.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1643-2026·2026-04-01
Olympus PKS Surgical Cutting Forceps recalled for defective welds
Olympus Corporation recalled PKS Cutting Forceps due to inadequate welding validation by suppliers, which can cause the device's jaw to break during surgical use.
Product
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2026·2026-04-01
I.T.S. Pelvic Reconstruction System MRI heating safety recall
The I.T.S. Pelvic Reconstruction System implants generate higher MRI-induced heating than documented in instructions. The FDA recalled approximately 46,637 units due to potential thermal injury risk during MRI procedures.
Product
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2026·2026-04-01
Orthopedic fibula plates may cause elevated heating during MRI procedures
I.T.S. fibula surgical plates may generate higher temperature increases during MRI scans than documented. Updated safety testing revealed the thermal risk under certain MRI conditions.
Product
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibul
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1632-2026·2026-04-01
Straumann Custom Titanium Abutments Recalled Due to Material Mix-up
Straumann USA is recalling 13 Custom Abutment Ti units due to a manufacturing error where the wrong material (TAN) was used instead of titanium. The affected units were distributed nationwide and to Canada.
Product
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2026·2026-04-01
Surgical humeral plate recalled for inaccurate MRI safety labeling
I.T.S. GmbH is recalling 292 Humeral Head Plates due to inaccurate MRI safety instructions. Updated testing shows RF heating risks are higher than previously documented.
Product
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2026·2026-04-01
Claviculaplate orthopedic implants recalled due to MRI thermal safety concerns
I.T.S. GmbH is recalling Claviculaplate orthopedic implants nationwide due to higher-than-documented radiofrequency-induced temperature increases during MRI scans. Updated MRI safety testing revealed the implants may generate more heat than previously indicated.
Product
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2026·2026-04-01
Calcaneus Repair System recalled for excessive MRI-induced heating
The FR.O.H. Calcaneus Repair System has been recalled due to higher-than-documented RF-induced temperature increases during MRI procedures. The manufacturer is updating safety instructions to reflect testing results.
Product
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2026·2026-04-01
Olympus Everest Bipolar Cutting Forceps Recalled for Defective Welds
Olympus Corporation is recalling 164 units of Everest Bipolar Cutting Forceps (Model 3006) due to defective welds in components that can cause the jaw to break during surgical use.
Product
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1644-2026·2026-04-01
Olympus PKS Cutting Forceps Recalled Due to Defective Welds
Olympus is recalling its PKS Cutting Forceps (Model 920005PK) because components contain defective welds that could cause the forceps' jaw to break during clinical use. Healthcare facilities should discontinue use and contact the manufacturer.
Product
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visuali
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1631-2026·2026-04-01
BiDop 3 Pocket Doppler recalled for unapproved fetal indication
Koven Technology is recalling 34 units of the BiDop 3 Pocket Doppler because the product labeling includes a fetal indication for use that was not cleared by the FDA through the 510(k) pre-market notification process.
Product
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2026·2026-04-01
Volar Radius Plate recalled for underestimated MRI heating risk
I.T.S. GmbH is recalling the Volar Radius Plate with Angular Stability (Radius Plate PROlock II) because updated MRI safety testing shows the device generates higher radiofrequency-induced heat during MRI scans than its Instructions for Use previously indicated.
Product
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2026·2026-04-01
Olympus Laparoscopic Cutting Forceps Recalled Due to Defective Welds
Olympus is recalling HALO PKS Cutting Forceps due to inadequate welding validation. Defective welds may cause the device's jaw to break during surgical use.
Product
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1638-2026·2026-04-01
Olympus Bipolar Cutting Forceps Recalled Over Defective Welds
Olympus recalled 106 Everest Bipolar Cutting Forceps (Model 3005) due to defective welds in supplier-provided components. The defect can cause the forceps' jaw to break during surgery.
Product
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1634-2026·2026-04-01
Intraocular lens delivery system recalled for possible deployment failure
TECNIS Eyhance intraocular lenses are being recalled because a haptic may stick to the optic, preventing proper unfolding during implantation. A limited quantity of 361 units was distributed nationwide.
Product
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0628-2026·2026-04-01
Tops GOLD Stuffed Red Chilli Pickle recalled for potential erucic acid contamination
Mangalm LLC is recalling Tops GOLD Stuffed Red Chilli Pickle due to potential adulteration with erucic acid from mustard oil. The affected product was distributed in CA, NV, OR, UT, and WA.
Product
Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:***Mustard Oil***
Category
Food
Distribution
5 states