Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

9351–9375 of 53039

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-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-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-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-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 (Drugs)·D-0432-2024·2024-04-10
Fentanyl Citrate Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
Product
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Category
Drug
Distribution
Distributed nationwide
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-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-1454-2024·2024-04-10
Medline wire cut scissors may have weak seal compromising sterility
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Product
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1113-2024·2024-04-10
Powerade Beverage Recall Due to Potential Metal Contamination
The Coca-Cola Company is recalling specific lots of Powerade Mountain Berry Blast distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in some bottles.
Product
Powerade Mountain Berry Blast - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1450-2024·2024-04-10
Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERI
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-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-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-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-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-1402-2024·2024-04-10
Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, 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-1469-2024·2024-04-10
Covidien Auto Suture blunt tip trocar recalled for seal disengagement
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1115-2024·2024-04-10
AJI MORI Chillimami Sauce Recalled for Potential Botulinum Contamination
AJI MORI Chillimami Sauce (250ml bottles) is being recalled due to potential contamination with Clostridium botulinum. The recall affects 78 bottles distributed to consumers in multiple states.
Product
AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT. 250ml. Packaged in a LDPE bottle. Refrigerate after opening.
Category
Food
Distribution
9 states
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-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-1472-2024·2024-04-10
Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation
FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.
Product
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
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