Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9451–9475 of 40056

HighFDA (Devices)·Z-2338-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility concerns
Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Specification Failure
Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2023·2023-08-09
Chest Stabilization Device Latch May Fail During Cardiac Surgery
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
Product
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2023·2023-08-09
Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction
Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2023·2023-08-09
Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.
Product
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2023·2023-08-09
Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction
Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2023·2023-08-09
OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.
Product
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2023·2023-08-09
Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction
Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2023·2023-08-09
X-ray Imaging System Carriage Bolts May Loosen or Break
Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.
Product
Allura Xper FD10 and FD20. X-ray Imaging System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2023·2023-08-09
OEC 9900 Systems Image Intensifier Detachment and Fall Risk
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Product
OEC 9900 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2023·2023-08-09
Medline procedural kits with ultrasound gel may not meet sterility specifications
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Failure
Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2023·2023-08-09
Medline procedural kits may contain non-sterile ultrasound gel
Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2023·2023-08-09
Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction
Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2023·2023-08-09
Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure
Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.
Product
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2263-2023·2023-08-09
Olympus Forceps Model INS-0362 Navigation Sensor Malfunction During Procedures
Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2308-2023·2023-08-09
Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2023·2023-08-09
Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns
Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2023·2023-08-09
MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction
Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.
Product
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2307-2023·2023-08-09
Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns
Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2312-2023·2023-08-09
Surgical Procedural Kits Recalled for Potential Sterility Specification Failures
Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2320-2023·2023-08-09
Medical procedural kits recalled for potential sterile ultrasound gel defect
Medline is recalling 93,587 custom procedural kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2023·2023-08-09
VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect
Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.
Product
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2309-2023·2023-08-09
Medline Procedural Kits with Ultrasound Gel Recalled for Sterility Risk
Medline is recalling 3,431 procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2023·2023-08-09
Medline surgical procedure kits recalled for potential sterility defect
Medline Industries is recalling 43,149 custom sterile and non-sterile procedural kits because the included Turkuaz ultrasound gel may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B…
Category
Medical Device
Distribution
Distributed nationwide

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