Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total: 536
Critical: 0
Severe: 56
Most recent: 2026-07-01

Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) 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 regulatory non compliance 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.

351–375 of 536

ModerateFDA (Devices)·Z-2219-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Implantable Staple Loading Units
EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2211-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Exchange Surgical Gowns
EXP Pharmaceutical Services Corp is recalling 10 units of Medical Device Exchange Surgical Gowns because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2226-2015·2015-08-05
EXP Recalls Unregistered Implantable Clips Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2278-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2239-2015·2015-08-05
EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur
EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2247-2015·2015-08-05
EXP Recalls Unregistered Surgical Routers for Crani-A Procedures
EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2225-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Suction Coagulator Devices
EXP Pharmaceutical Services Corp is recalling sterile suction coagulator devices because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2238-2015·2015-08-05
EXP recalls Stryker Round Fluted Burs due to registration violations
EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2227-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems
EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2230-2015·2015-08-05
EXP Recalls Fiberwire Suture Scissors Due to Registration Violations
EXP Pharmaceutical Services Corp is recalling Fiberwire Suture Scissors because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2243-2015·2015-08-05
EXP Recalls PhysioMesh Surgical Mesh Due to Registration Violations
EXP Pharmaceutical Services Corp is recalling PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2223-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Suction Devices
EXP Pharmaceutical Services Corp is recalling sterile suction devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2220-2015·2015-08-05
EXP recalls 12 unregistered sterile dilating tip trocars
EXP Pharmaceutical Services Corp is recalling 12 sterile dilating tip trocars because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2242-2015·2015-08-05
EXP Recalls PhysioMesh Surgical Mesh Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2236-2015·2015-08-05
EXP Recalls Unregistered Orthopedic Saw Blades Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-2279-2015·2015-08-05
Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance
Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.
Product
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2240-2015·2015-08-05
EXP Recalls 6.0mm Round Fluted Bur Due to Registration Deficiencies
EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2147-2015·2015-07-29
CooperSurgical Recalls Infant Heel Warmers for Lack of FDA Clearance
CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.
Product
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2169-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2192-2015·2015-07-29
Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance
Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.
Product
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1638-2015·2015-06-17
GE OEC Brivo 865 Plus Mobile X-ray Laser Aimer Assemblies Recalled
GE OEC Medical Systems is recalling nine mobile X-ray laser aimer assemblies because they were shipped without required laser product certification.
Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1555-2015·2015-05-27
Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep
Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.
Product
Philips Healthcare DuraDiagnost X- Ray
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1636-2015·2015-05-27
MelaFind Device Recalled for Unapproved User Interface Data Display
MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.
Product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Category
Medical Device
Distribution
21 states
LowFDA (Drugs)·D-1077-2015·2015-05-20
FDA Recalls Monistat 1 Simple Cure for Missing Topical Cream
Medtech Products, Inc. is recalling Monistat 1 Simple Cure because the distributed units lack the required topical cream.
Product
MONISTAT 1 COMBINATION PACK — MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1539-2015·2015-05-06
Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna because the product was distributed without the required FDA 510(k) approval.
Product
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide