Hazard

Sterility Risk recalls

288 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 288
Critical: 0
Severe: 50
Most recent: 2026-07-29

Of the 288 sterility risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 50 (17%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 288

SevereFDA (Drugs)·D-0720-2026·2026-07-29
FDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.
Product
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2038-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1780-2026·2026-04-15
Blue Rhino G2-Multi tracheostomy introducer trays carry overstated expiration dates
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 441 units are affected.
Product
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1791-2026·2026-04-15
Cook Medical Wayne pneumothorax sets carry overstated expiration dates
Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.
Product
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1786-2026·2026-04-15
Cook Medical multipurpose drainage catheters carry overstated expiration dates
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Product
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1788-2026·2026-04-15
Cook Medical central venous catheter sets labeled with overstated expiration dates
Cook Medical is recalling Spectrum Central Venous Catheter Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 5,080 units are affected.
Product
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1787-2026·2026-04-15
Cook Medical nitinol stone extractors labeled with overstated expiration dates
Cook Medical is recalling NCompass Nitinol Stone Extractors because affected lots were labeled with expiration dates that exceed the product's true shelf life. 70 units are affected.
Product
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1778-2026·2026-04-15
Cook Medical arterial pressure monitoring trays carry overstated expiration dates
Cook Medical is recalling Arterial Pressure Monitoring Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Product
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1789-2026·2026-04-15
Cook Medical Spectrum central venous trays carry overstated expiration dates
Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.
Product
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1790-2026·2026-04-15
Cook Medical chest tube tray labeled with an overstated expiration date
Cook Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.
Product
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1783-2026·2026-04-15
Cook Medical Spectrum central venous catheter trays carry overstated expiration dates
Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.
Product
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1784-2026·2026-04-15
Cook Medical bile duct exploration sets labeled with overstated expiration dates
Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
Product
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1781-2026·2026-04-15
Cook Medical tracheostomy introducer sets labeled with overstated expiration dates
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.
Product
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1792-2026·2026-04-15
Cook Medical pneumothorax tray labeled with an overstated expiration date
Cook Medical is recalling Wayne Pneumothorax Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 318 units are affected.
Product
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Par
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1785-2026·2026-04-15
Cricothyrotomy catheter sets labeled with overstated expiration dates
Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.
Product
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1776-2026·2026-04-15
Cook Medical micro wire guides labeled with overstated expiration dates
Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
Product
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1777-2026·2026-04-15
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.
Product
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1779-2026·2026-04-15
Blue Rhino G2-Multi tracheostomy introducer sets carry overstated expiration dates
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.
Product
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Refer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1782-2026·2026-04-15
Cook Medical extubation set labeled with an overstated expiration date
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
Product
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1418-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1883-2025·2025-06-04
Ethos Collar Stem components recalled for potential Tyvek seal breach
Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.
Product
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1595-2025·2025-04-23
Medline dental convenience kits recalled for potential weak seal packaging
Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.
Product
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841
Category
Medical Device
Distribution
Distributed nationwide