Hazard

Quality System Failure recalls

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

What the numbers show

Total: 26
Critical: 0
Severe: 0
Most recent: 2025-10-22

Of the 26 quality system failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 quality system failure 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 26

ModerateFDA (Drugs)·D-0027-2026·2025-10-22
Sucralfate tablets recalled after bankruptcy left quality program unmonitored
Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.
Product
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0783-2017·2016-12-28
Ultroid Mobile Generator and Sterile Probes Recalled for Quality System Failures
Ultroid Technologies is recalling 62 mobile generator units and sterile probes because they were not manufactured under required quality system controls.
Product
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Category
Medical Device
Distribution
34 states
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-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-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-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-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-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-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-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
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-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-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-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-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