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

11676–11700 of 40112

LowFDA (Devices)·Z-0132-2023·2022-11-02
Vortex MP Port Titanium Recalled for Missing Printed Instructions
Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.
Product
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0075-2023·2022-10-26
Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk
TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.
Product
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0074-2023·2022-10-26
Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk
Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.
Product
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0076-2023·2022-10-26
Medical gas filter recalled due to splitting and detachment risk
TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.
Product
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0077-2023·2022-10-26
Teleflex Catheter Mount and Filter May Split or Detach During Use
Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.
Product
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0072-2023·2022-10-26
Iso-Gard Filter S Recalled for Device Splitting or Detachment During Use
Teleflex is recalling Iso-Gard Filter S microbial filters (60,500 units) due to incidents of device splitting or detaching during use. The filters protect patients and equipment from bacterial and viral contamination in breathing systems.
Product
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0073-2023·2022-10-26
Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment
TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.
Product
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0094-2023·2022-10-26
N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.
Product
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2023·2022-10-26
Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component
Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.
Product
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0116-2023·2022-10-26
Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.
Product
Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2023·2022-10-26
MitraClip Clip Delivery System Recalled for Locking Malfunctions
Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.
Product
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0099-2023·2022-10-26
Surgical Implant Kit Recall: Incorrect Drill Guide Included
Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.
Product
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0100-2023·2022-10-26
Synthes SPEED implant recall: drill guide size mismatch in surgical kit
Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.
Product
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0112-2023·2022-10-26
Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.
Product
Medicina Reusable Oral syringe 1ml Code: OTH01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0113-2023·2022-10-26
Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.
Product
Medicina Reusable Oral syringe 5ml Code: OTH05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0102-2023·2022-10-26
ARROW Midline Catheter Kit Mislabeled with Wrong Device Type
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
Product
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0092-2023·2022-10-26
IV extension set recall for potential joint failure and leakage risk
B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.
Product
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0110-2023·2022-10-26
Oral Tip Syringes Recalled Due to Unapproved Plunger Material
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
Product
Medicina Oral Tip Syringe 1ml Code: OT01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2023·2022-10-26
ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
Product
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0104-2023·2022-10-26
Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer
The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.
Product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0109-2023·2022-10-26
Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material
Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.
Product
Medicina Oral Tip Syringe 0.5ml Code: OT005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0096-2023·2022-10-26
Laryngeal mask airway recalled for incorrect size marking
Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.
Product
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0105-2023·2022-10-26
Medical device assay may report falsely elevated lithium levels
Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0101-2023·2022-10-26
DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2023·2022-10-26
BD Vacutainer Blood Alcohol Testing Tubes Recalled for Analytical Interference
BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.
Product
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Category
Medical Device
Distribution
Distributed nationwide

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11676–11700 of 40112