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 13748

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
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-1062-2023·2023-02-15
Medline sterile procedural trays recalled for blade packaging puncture
Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.
Product
LOCAL PACK. Sterile Procedural Tray.
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-1098-2023·2023-02-15
Zimmer Identity Shoulder Resection Planer Units Recalled for Malfunction
Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer due to defects discovered during training testing. Some units are unusable, potentially affecting surgical performance in shoulder procedures.
Product
Identity Shoulder System Resection Planer 35mm Resection Planer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
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-1101-2023·2023-02-15
RipCord Syndesmosis Button suture may break during orthopedic surgery
The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.
Product
RipCord Syndesmosis Button, REF: STA001K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1063-2023·2023-02-15
Medline Sterile Procedural Trays recalled due to packaging defect risk
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2023·2023-02-15
Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
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-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-1089-2023·2023-02-15
Sterile surgical trays recalled due to packaging puncture risk
MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
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-1077-2023·2023-02-15
Sterile Surgical Trays Recalled for Blade Puncture of Packaging
Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR
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-1072-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk
Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l
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-1105-2023·2023-02-15
Roche cobas Influenza Test Recall Due to False Negative Results
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Product
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1095-2023·2023-02-15
Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk
Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2023·2023-02-15
Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l
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-1090-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Compromise
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
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-1087-2023·2023-02-15
Medline Procedural Trays Recalled for Blade Packaging Risk
Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Category
Medical Device
Distribution
Distributed nationwide

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9901–9925 of 13748