Hazard

Labeling Inconsistency recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2025-12-17

Of the 9 labeling inconsistency 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 labeling inconsistency 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.

1–9 of 9

ModerateFDA (Devices)·Z-0895-2026·2025-12-17
Titanium spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 14,201 Forza Ti Spacer System units because the labeling contains claims that are not consistently present.
Product
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0894-2026·2025-12-17
Sacroiliac fusion screws recalled over labeling claims not consistently present
Orthofix U.S. is recalling 19,431 FIREBIRD SI Fusion System units because the labeling contains claims that are not consistently present.
Product
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0893-2026·2025-12-17
PTC spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 13,317 Pillar SA PTC Spacer System units because the labeling contains claims that are not consistently present.
Product
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0891-2026·2025-12-17
Mini PTC spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 61,977 CONSTRUX Mini PTC Spacer System units because the labeling contains claims that are not consistently present.
Product
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0250-2026·2025-12-17
PTC spinal spacers recalled over labeling claims not consistently present
Orthofix U.S. is recalling 34,582 FORZA PTC Spacer System units because the labeling contains claims that are not consistently present.
Product
Deep-brand Premium Select Surti Undhiu Mix Net Wt. 12 oz. (340 g) KEEP FROZEN
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0896-2026·2025-12-17
Titanium spinal spacers recalled over labeling claims not consistently present
Orthofix U.S. is recalling 40,956 CONSTRUX Mini Ti Spacer System units because the labeling contains claims that are not consistently present.
Product
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2289-2025·2025-08-20
Plastic trial heads carry inconsistent size terminology and color coding
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2288-2025·2025-08-20
Prosthesis heads carry inconsistent size terminology and color coding on labeling
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.
Product
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2208-2016·2016-07-27
Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation
Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.
Product
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for card
Category
Medical Device
Distribution
51 states