Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
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.
Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set due to a potential for blockage of the Hub Attachment Tube.
Medline Industries is recalling 500 units of DYNDA1928 VP Trays because the sterile wrap may become loose in transit, compromising the sterile barrier.
GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could cause incorrect dates to be recorded on medical images.
Vitreq Bv is recalling VitreQ 23G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.
MPRX, Inc. dba Medical Park Pharmacy is recalling Liothyronine (T3) 80 mcg SR capsules compounded with expired components and missing labeling.
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.
MPRX, Inc. is recalling Progesterone 200 mg Troche due to incorrect labeling and the use of expired components in compounding.
Brasseler USA is recalling 103 tubes of Steinmann Pins that were incorrectly labeled as threaded pins instead of smooth pins.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner cap may open or the tube may remain in the outer cap, preventing screw removal.
McGuff Compounding Pharmacy Services, Inc. is recalling Dimercaptopropanesulfonate Sodium (DMPS) injection vials due to the presence of particulate matter.
MPRX, Inc. is recalling Magic Bullet Supplement bottles compounded with expired components and incorrect labeling. The recall affects products distributed in Texas.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open or fail to separate, potentially delaying surgery.
MPRX, Inc. dba Medical Park Pharmacy is recalling Testosterone Topical Cream 4% because it was compounded using expired components and has incorrect or missing lot and expiration dates.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw accessible, potentially delaying surgery.
GE Healthcare is recalling SIGNA Architect MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.
Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.
Healthy Food Ingredients, LLC is recalling Organic IntegriPure Cold Milled Flaxseed in 50 lb and 2,000 lb totes due to the detection of an unapproved herbicide.
MPRX, Inc. is recalling Progesterone 50 mg capsules compounded with expired components due to incorrect or missing lot and expiration dates.
MPRX, Inc. dba Medical Park Pharmacy is recalling Naltrexone 4.5 mg capsules because they were compounded using expired components and have incorrect or missing lot and expiration dates.
Collagen Matrix Inc is recalling GIBSON Healthcare Membrane 6-9 units because they may have been packaged with incorrect Instructions for Use.
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.
MPRX, Inc. dba Medical Park Pharmacy is recalling Liothyronine (T3) 92.5 MCG compounded with expired components due to incorrect or missing lot and expiration dates.
MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 20 mg Troche because the products were compounded using expired components and have incorrect or missing lot and expiration dates.
MPRX, Inc. dba Medical Park Pharmacy is recalling T3/T4 SR 9 mcg/38 mcg capsules due to incorrect or missing lot and expiration dates and the use of expired components.
Northwest Gourmet Food Products Inc. is recalling Pike Place Chowder New England Clam Chowder because the outer packaging claims 'Gluten Free' while the inner pouch declares wheat.