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

7501–7525 of 39844

HighFDA (Devices)·Z-1416-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect
Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.
Product
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2024·2024-04-10
Medline Centurion surgical kits recalled due to weak seal
Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.
Product
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2024·2024-04-10
Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
Product
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2024·2024-04-10
Covidien Auto Suture Trocar Recall: Potential Seal Disengagement With Incorrect Mesh Use
Covidien is recalling 93,673 Auto Suture Blunt Tip Trocars due to potential seal disengagement when mesh products are used incorrectly. Improper use could compromise device integrity during laparoscopic procedures.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2024·2024-04-10
ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.
Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2024·2024-04-10
Covidien Auto Suture Trocar Recalled for Potential Seal Disengagement
Covidien is recalling approximately 124,863 Auto Suture Structural Balloon Trocars worldwide due to potential seal disengagement when used incorrectly with mesh products.
Product
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2024·2024-04-10
BD Phoenix diagnostic panel recalled for drug cross-contamination
Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.
Product
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1430-2024·2024-04-10
Sterile blood collection tubes recalled for weak seal defect
MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.
Product
Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1458-2024·2024-04-10
Covidien Signia Surgical Stapler Reloads Recalled Due to Articulation Defect
Covidien is recalling certain Signia surgical stapler reloads due to unsecured components that can cause uncontrolled articulation during use, potentially disrupting the staple line. The recall affects 3,023 units distributed worldwide.
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1434-2024·2024-04-10
Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach
Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.
Product
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2024·2024-04-10
Suture Removal and Staple Remover Kits Recalled for Weak Seal
Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.
Product
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1460-2024·2024-04-10
Trumpet Needle Guide Ring May Detach Under Excessive Pressure
Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.
Product
Trumpet, Needle Guide, Cat# TMS-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2024·2024-04-10
Exactech Shoulder Implant Liners Recalled for Defective Oxygen Barrier Packaging
Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.
Product
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2024·2024-04-10
Centurion Manual Surgical Kits Recalled Due to Weak Seal
Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.
Product
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2024·2024-04-10
Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 he
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2024·2024-04-10
Exactech Equinoxe shoulder arthroplasty glenoid components recalled for packaging defects
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2024·2024-04-10
Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2024·2024-04-10
Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.
Product
Ureteral dilator, REF RBD014
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1449-2024·2024-04-10
Centurion Manual surgical kits recalled due to weak seals risking sterility breach
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Product
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2024·2024-04-10
Laryngeal Mirror Weak Seal May Breach Sterility
Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.
Product
Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2024·2024-04-10
Medline Centurion surgical scissors recalled due to weak seals
Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.
Product
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2024·2024-04-10
Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk
Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2024·2024-04-10
Centurion umbilical cord clamp cutter recalled for potential sterility breach
Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.
Product
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1480-2024·2024-04-10
Abbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.
Product
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Category
Medical Device
Distribution
Distributed nationwide

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7501–7525 of 39844