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.

326–350 of 536

ModerateFDA (Devices)·Z-2218-2015·2015-08-05
EXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar devices because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2277-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2228-2015·2015-08-05
EXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues
EXP Pharmaceutical Services Corp is recalling two units of specimen retriever bags because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2241-2015·2015-08-05
EXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices
EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.
Product
Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2244-2015·2015-08-05
EXP Pharmaceutical Services Recalls SECURESTRAP Absorbable Strap Fixation Devices
EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation Devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2235-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
EXP Pharmaceutical Services Corp is recalling a medical device exchange product because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2233-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders
EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2274-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance
Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical sampl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2214-2015·2015-08-05
EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure
EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2212-2015·2015-08-05
EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations
EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2231-2015·2015-08-05
EXP Recalls Unregistered Stryker Femoral Canal Tips
EXP Pharmaceutical Services Corp is recalling 12 Stryker Femoral Canal Tips because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2217-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered GIA Auto Suture Loading Units
EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2232-2015·2015-08-05
EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles
EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2234-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders
EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2275-2015·2015-08-05
Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance
Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2213-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches
EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2229-2015·2015-08-05
EXP Recalls ETS FLEX 45 Endoscopic Articulating Linear Cutters
EXP Pharmaceutical Services Corp is recalling ETS FLEX 45 endoscopic cutters because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2237-2015·2015-08-05
EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires
EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2216-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Endo Catch Medical Devices
EXP Pharmaceutical Services Corp is recalling two units of Endo Catch 10mm devices because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2222-2015·2015-08-05
EXP Pharmaceutical Services Recalls Mayfield Disposable Skull Pins
EXP Pharmaceutical Services Corp is recalling Mayfield Disposable Skull Pins because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2251-2015·2015-08-05
EXP Recalls Chocolate Balloon Catheters Due to Registration Deficiencies
EXP Pharmaceutical Services Corp is recalling one unit of a Chocolate Balloon Catheter because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2224-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Auto Suture Endo Universal Devices
EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2250-2015·2015-08-05
EXP Pharmaceutical Services Recalls Angio-Seal Vascular Closure Devices
EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure devices due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2221-2015·2015-08-05
EXP recalls 12mm Dilating Tip Trocars due to registration violations
EXP Pharmaceutical Services Corp is recalling 12mm 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 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2248-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations
EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.
Product
Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Category
Medical Device
Distribution
6 states