Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16001–16025 of 21645

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 (Food)·F-2899-2015·2015-08-05
Dairy Farmers of America Recalls Swiss Cheese Slices Due to Plastic Film
Dairy Farmers of America is recalling specific Swiss imitation cheese products because a piece of plastic film might remain attached to the slices.
Product
Imitation Pasteurized Process Cheese Food: SANDWICH MATE 12/10.67OZ SINGLES, SWISS IMIT WHT, 7103025172. VALU TIME 12/10.67OZ SWISS Flavored sandwich slices, IMIT WHT, 1122502481. Sandwich MATE 12/8OZ SWISS flavor singles, IMIT PP.99 WHT, 7103025175
Category
Food
Distribution
39 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-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 (Drugs)·D-1281-2015·2015-08-05
Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.
Product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2309-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 178 G1 dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure than labeled.
Product
ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2313-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 686 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 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
ModerateFDA (Food)·F-2874-2015·2015-08-05
Dairy Farmers of America Recalls Pepper Jack Cheese Due to Plastic Film
Dairy Farmers of America is recalling Hyvee Pepper Jack cheese because plastic film may remain attached to the slices.
Product
Flavored Pasteurized Prepared Cheese Product: HYVEE 12/12OZ PEPPER JACK CHS PROD, 7545009334.
Category
Food
Distribution
39 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2290-2015·2015-08-05
Anspach Fluted Ball Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
Product
ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2297-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 95 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed attachments, potentially resulting in greater exposure than specified.
Product
ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2252-2015·2015-08-05
EXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2312-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2883-2015·2015-08-05
Dairy Farmers of America Recalls Borden Mozzarella Slices Due to Plastic Film
Dairy Farmers of America is recalling Borden 2% Light Mozzarella Reduced Fat Slices because a piece of plastic film strip might remain attached to the cheese.
Product
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/6.56OZ 2% LIGHT MOZZARELLA REDUCED FAT SLICES, 5300001605.
Category
Food
Distribution
39 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-2294-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 92 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
Product
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 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 (Food)·F-2878-2015·2015-08-05
Dairy Farmers of America Recalls White Cheddar Cheese Alternative Slices
Dairy Farmers of America is recalling SOYA KAAS White Cheddar Flavor Cheese Alternative slices because a piece of plastic film might remain attached to the cheese.
Product
White Cheddar Flavor Cheese Alternative: SOYA KAAS 12/8OZ WHITE CHEDDAR FLAVOR SLICES, 7801600478.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2215-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2280-2015·2015-08-05
Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 65 Fluted Drum dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.
Product
ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2273-2015·2015-08-05
Hardy Diagnostics Recalls MacConkey Agar and Other Media for Lack of Clearance
Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2881-2015·2015-08-05
Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard
Dairy Farmers of America is recalling reduced-fat cheese products because a piece of plastic film strip might remain attached to the cheese slice.
Product
Reduced Fat Pasteurized Prepared Cheese Product: MEIJER 12/12OZ 2PCT AMER YLW,4125005136. ESSENTIAL EVERYDAY 12/10.7 OZ 2% AMER PROC YLW, 4130300844. BORDEN 12/6.56OZ 2% AMER YLW, 5300000605. BORDEN 12/10.67OZ 2% AMER SINGLES,2.99, 5300000693. HARRIS TEETER 12/12OZ 2%…
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2897-2015·2015-08-05
Dairy Farmers of America Recalls Imitation Process Cheese Food Due to Plastic Film
Dairy Farmers of America Inc. is recalling imitation pasteurized process cheese food products because a piece of plastic film strip might remain attached to the cheese slice.
Product
Imitation Pasteurized Process Cheese Food: VALUE TIME 12/8OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122509140. VALUE TIME 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122558045. VALUE TIME…
Category
Food
Distribution
39 states
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