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

6826–6850 of 13652

HighFDA (Devices)·Z-1415-2024·2024-04-10
Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
Product
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2024·2024-04-10
Exactech Equinoxe shoulder components recalled for nonconforming packaging
Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product specifications.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
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-1459-2024·2024-04-10
Medline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
Product
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2024·2024-04-10
Medline Centurion Surgical Forceps Kits Recalled for Defective Seals
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Product
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERIL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
Product
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2024·2024-04-10
Skull Anchor Key Defect Prevents CT Localizer Attachment
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2024·2024-04-10
Centurion Curette kits recalled for weak seals potentially compromising sterility
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
Product
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1477-2024·2024-04-10
Stryker Infinity Resection Adjustment Block Recall: Missing Locking Screw
Stryker recalled specific lots of Infinity Resection Adjustment Blocks due to a missing internal screw that locks the medial/lateral adjustment mechanism. The defect affects 47 units used in ankle arthroplasty procedures.
Product
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1435-2024·2024-04-10
Centurion Surgical Hook Kits Recalled Due to Weak Seal
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
Product
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1479-2024·2024-04-10
ARCHITECT Anti-HCV Reagent Kit Recalled for False Positive Results
Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.
Product
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
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-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-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-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-1457-2024·2024-04-10
Signia Surgical Stapler Reload recalled for uncontrolled articulation
Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.
Product
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2024·2024-04-10
Centurion Clamp kits recalled due to potential sterility breach risk
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Product
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2024·2024-04-10
Exactech Equinoxe Shoulder Components Recalled for Packaging Defect
Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2024·2024-04-10
Torrent Suite Dx Software versions affected by cybersecurity vulnerability
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.
Product
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The
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-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-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-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-1428-2024·2024-04-10
Medline Pediatric Magill Catheter Recalled for Weak Seal Risk
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Product
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
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

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6826–6850 of 13652