Hazard

Sterility Compromise recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise 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.

201–225 of 328

HighFDA (Devices)·Z-1118-2023·2023-02-22
Surgical Convenience Kits Recalled Due to Compromised Sterility of External Wrapping
Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.
Product
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PROD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2023·2023-02-22
Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise
Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.
Product
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2023·2023-02-22
Surgical kits recalled due to compromised sterile wrapping
Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.
Product
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2023·2023-02-22
Surgical Convenience Kits Recalled for Compromised Sterility Assurance
Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.
Product
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2023·2023-02-22
Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect
Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.
Product
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1115-2023·2023-02-22
Surgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility
Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.
Product
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1110-2023·2023-02-22
Surgical angio port kits recalled for compromised sterile barrier
Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.
Product
Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2023·2023-02-22
Surgical convenience kits recalled for sterile barrier defect
Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.
Product
Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture
Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1070-2023·2023-02-15
Sterile Procedural Trays recalled for potential blade puncture of packaging
Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.
Product
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2023·2023-02-15
Sterile endoscopy trays recalled for potential blade packaging puncture
Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2023·2023-02-15
Sterile Surgical Trays Recalled for Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.
Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1095-2023·2023-02-15
Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk
Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
Product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Puncture
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2023·2023-02-15
Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk
Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: LS MS PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.
Product
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1080-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Category
Medical Device
Distribution
Distributed nationwide