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.

401–425 of 536

LowFDA (Devices)·Z-0541-2015·2014-12-17
Hudson cerebellar extensions recalled for pre-amendment marketing status issues
Instrumed International is withdrawing Hudson cerebellar extensions because they were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0537-2015·2014-12-17
Instrumed Recalls Manual Bunnell Cranial Drills for Regulatory Non-Compliance
Instrumed International is withdrawing 13 manual Bunnell cranial drills because the company did not market them before 1976, failing FDA pre-amendment requirements.
Product
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0540-2015·2014-12-17
Instrumed Recalls Hudson Braces for Regulatory Compliance Issues
Instrumed International is withdrawing Hudson braces from the market because the devices do not meet FDA requirements for pre-amendment status.
Product
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0535-2015·2014-12-17
Instrumed Recalls Surgical Trocars Due to Regulatory Non-Compliance
Instrumed International is withdrawing 11 surgical trocars because they do not meet FDA requirements for pre-amendment devices.
Product
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0557-2015·2014-12-17
Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.
Product
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0559-2015·2014-12-17
Instrumed Recalls Schoitz Weights for Regulatory Compliance Issues
Instrumed International is withdrawing Schoitz weights from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (app
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0545-2015·2014-12-17
Instrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
Instrumed International is withdrawing McKenzie Perforator Drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0538-2015·2014-12-17
Instrumed Recalls Mogen Circumcision Clamps for Regulatory Non-Compliance
Instrumed International is withdrawing 421 Mogen circumcision clamps because the company did not market these devices prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0475-2015·2014-12-03
Dharma Cavity Varnish Recalled for Lack of FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).
Product
Dharma Cavity Varnish with Fluoride
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0477-2015·2014-12-03
ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing
ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is und
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0476-2015·2014-12-03
Dharma Cavity Varnish Recalled for Missing FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.
Product
Dharma Cavity Varnish 15mL
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0222-2015·2014-11-26
Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change
Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.
Product
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-0097-2015·2014-11-05
Heather's Choice Recalls Salmon Chowder for Undeclared Coconut and Permit Issues
Heather's Choice is recalling Salmon Chowder because the firm operated without a permit and lacked a HACCP plan. The product also contains undeclared coconut.
Product
Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: "***Salmon Chowder***HEATHER'S CHOICE***meals for adventuring***ingredients: salmon + peas + carrots + potatoes+ coconut milk powder***directions: cover food with hot water + let sit for 15 mi
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0098-2015·2014-11-05
Heather's Choice Rancheros Recalled for Operating Without Permit and HACCP Plan
Heather's Choice is recalling Rancheros because the firm operated without a permit and lacked a HACCP plan.
Product
Rancheros, sold under brand Heather's Choice. The product is labeled in parts: "***Rancheros***HEATHER'S CHOICE***meals for adventuring***ingredients: bison + yams + tomatoes + onions + tomatillos + garlic + jalapenos + green bell peppers***directions: cover food with hot wa
Category
Food
Distribution
0 states
LowFDA (Drugs)·D-0049-2015·2014-11-05
Taro Pharmaceuticals Recalls Carbamazepine Tablets Sold Without Approval
Taro Pharmaceuticals is recalling 1,966 bottles of Carbamazepine 200 mg tablets because they were sold without an approved NDA/ANDA.
Product
CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D0030-2015·2014-10-29
New GPC Inc. Recalls Alcosulph Astringent Lotion for Labeling Deficiencies
New GPC Inc. is recalling Alcosulph Astringent Lotion because it lacks required drug listings and OTC labeling, and is labeled as not approved for sale in the U.S.
Product
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D0033-2015·2014-10-29
New GPC Inc. Recalls Whitfield Lotion for Labeling Deficiencies
New GPC Inc. is recalling 360 units of Whitfield Lotion in New York because the product lacks required OTC drug listing and labeling.
Product
WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D0032-2015·2014-10-29
New GPC Inc. Recalls Ferrol Expectorant for Labeling Deficiencies
New GPC Inc. is recalling Ferrol Expectorant because the product lacks required OTC drug listings and labeling, and is labeled as not approved for sale in the U.S.
Product
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D0034-2015·2014-10-29
New GPC Inc. Recalls Whitfield's Ointment for Labeling Deficiencies
New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.
Product
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D0031-2015·2014-10-29
New Gpc Inc. Recalls Mustarcreme for Labeling and Listing Deficiencies
New Gpc Inc. is recalling Mustarcreme units in New York because the product lacks required drug listings, OTC labeling, and is marked not approved for U.S. sale.
Product
MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D0029-2015·2014-10-29
New GPC Inc. Recalls Alcosulph Moisturizing Cream for Labeling Deficiencies
New GPC Inc. is recalling Alcosulph Moisturizing Cream because it lacks required OTC drug listings and labeling, and is marked not approved for sale in the U.S.
Product
alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana.
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-2734-2014·2014-10-08
Baro-Therapies Rejuvenator Chamber Recalled for Lack of FDA Approval
Baro-Therapies, Inc. is recalling 10 Rejuvenator Chambers because they were distributed without an approved 510(k).
Product
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2688-2014·2014-10-01
Smith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems
Smith & Nephew is recalling RENASYS EZ Negative Pressure Wound Therapy Systems because modifications were made without required FDA notifications.
Product
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Category
Medical Device
Distribution
Distributed nationwide
SevereUSDA FSIS·062-2014·2014-09-27
Delicious Beef Jerky Recalled for Missing Inspection Mark
Delicious Beef Jerky, LLC is recalling 8 pounds of Lemon Pepper Seasoned Beef Jerky because the products were produced and shipped without the required USDA inspection.
Product
Delicious Beef Jerky — New Mexico Firm Recalls Beef Jerky Products Incorrectly Produced and Shipped with the Mark of Inspection
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2645-2014·2014-09-24
FDA Recalls Ultraslim Devices for Marketing Without Clearance
Advanced Photonic Systems is recalling 235 Ultraslim devices because they were marketed without FDA clearance or approval.
Product
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims th
Category
Medical Device
Distribution
24 states