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 deaths or serious injuries are reported, 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

9901–9925 of 13731

HighFDA (Devices)·Z-1066-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Over Blade Puncture Risk
Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.
Product
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2023·2023-02-15
Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
Product
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2023·2023-02-15
Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture
Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.
Product
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Puncture
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2023·2023-02-15
Sterile Procedural Trays recalled due to potential sterile packaging puncture
Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: IM NAIL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk
Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.
Product
ANCILLARY PACK-LF. Sterile Procedural Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2023·2023-02-15
Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results
Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.
Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1070-2023·2023-02-15
Sterile Procedural Trays recalled for potential blade puncture of packaging
Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.
Product
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2023·2023-02-15
Sterile Procedural Trays With Blades That May Puncture Packaging
Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2023·2023-02-15
Precision Delivery Sets recalled due to potential tubing detachment
Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.
Product
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1108-2023·2023-02-15
Vascular Covered Stent Recalled Due to Deployment Failure Risk
Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.
Product
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1080-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1103-2023·2023-02-15
Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging
Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.
Product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1093-2023·2023-02-15
Sterile Surgical Trays Recalled for Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.
Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
Product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2023·2023-02-15
Sterile arthroscopy trays recalled for potential blade puncture risk
Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture
Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1107-2023·2023-02-15
Surgical instrument tracker recalled for structural failure during use
Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.
Product
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1078-2023·2023-02-15
Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWE
Category
Medical Device
Distribution
Distributed nationwide

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9901–9925 of 13731