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

6701–6725 of 13543

HighFDA (Devices)·Z-1448-2024·2024-04-10
Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2024·2024-04-10
Mobile X-ray System Structural Cable Defect Affects Safety Function
Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.
Product
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300
Category
Medical Device
Distribution
Distributed nationwide
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-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-1446-2024·2024-04-10
Sterile Rubber Band Recall for Weak Seal Risk
Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.
Product
Centurion STERILE #16 RUBBER BAND, Product Code EB16
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-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-1427-2024·2024-04-10
Centurion Sterile Trach Brush Recalled Due to Weak Seal
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
Product
Centurion STERILE TRACH BRUSH, Product Code 6225ST
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-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-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-1447-2024·2024-04-10
Centurion PICC Line Securement Kit Recalled for Weak Seal
MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.
Product
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2024·2024-04-10
Centurion Scalpel Handles Recalled Due to Weak Seal Risk
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
Product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
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-1441-2024·2024-04-10
Centurion Surgical Instrument Kits Recalled for Potentially Weak Seals
Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.
Product
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2024·2024-04-10
Abbott ARCHITECT STAT Myoglobin Reagent Kit recalled due to manufacturing defect
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
Product
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
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-1410-2024·2024-04-10
Exactech Shoulder Implants Recalled for Improper Packaging Defect
Exactech Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2024·2024-04-10
Covidien Trocar Recall Due to Potential Seal Disengagement with Mesh
Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1473-2024·2024-04-10
Surgical Optical Scissors Recalled Due to Inadequate Reprocessing Evidence
Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.
Product
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Liners Recalled for Packaging Nonconformance
Exactech recalls 66,646 Equinoxe Reverse Shoulder humeral liners due to nonconforming packaging lacking required oxygen barrier protection. The missing EVOH layer means units do not meet established packaging specification.
Product
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
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-1433-2024·2024-04-10
Centurion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk
Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination if the seal fails.
Product
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1401-2024·2024-04-10
Cardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.
Product
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534
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

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6701–6725 of 13543