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.

18776–18800 of 21645

ModerateFDA (Devices)·Z-0984-2014·2014-02-26
Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings
Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.
Product
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1031-2014·2014-02-26
Zimmer Recalls 12/14 Femoral Heads Due to Packaging Validation Issues
Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1021-2014·2014-02-26
Zimmer Recalls Knee Implant Components Due to Packaging Validation Issues
Zimmer is recalling specific knee implant components because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1010-2014·2014-02-26
Zimmer Recalls Interlocking IM Screws Due to Packaging Validation Issues
Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1013-2014·2014-02-26
Zimmer Recalls ITST Anti-Rotation Screws and Femoral Intramedullary Nails
Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.
Product
ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1036-2014·2014-02-26
Zimmer Recalls CPT Degree Taper and Femoral HD Medical Devices
Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.
Product
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1016-2014·2014-02-26
Zimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations
Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1039-2014·2014-02-26
Zimmer Recalls Compression Screws Due to Packaging Validation Review
Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1040-2014·2014-02-26
Zimmer Recalls Orthopedic Screws Due to Packaging Validation Deficiencies
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1020-2014·2014-02-26
Zimmer Recalls NEXGEN Osteotomy Cortical Bone Screws Due to Packaging Validation
Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1027-2014·2014-02-26
Zimmer Recalls Pressfit Femoral Stems Due to Packaging Validation Issues
Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.
Product
PRESSFIT FEM ST FX 16 X 1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1037-2014·2014-02-26
Zimmer Recalls FEM HD ION Hip Implants Due to Packaging Validation Issues
Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
FEM HD ION (various sizes)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1028-2014·2014-02-26
Zimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues
Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
VERSYS HERITAGE FEM STEM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1002-2014·2014-02-26
Zimmer Recalls Bone Screws Due to Packaging Validation Deficiencies
Zimmer is recalling specific bone screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1019-2014·2014-02-26
Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1035-2014·2014-02-26
Zimmer Recalls Modular Hip Implants Due to Packaging Validation Issues
Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.
Product
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2014·2014-02-26
Synthes 3.2 mm Guide Wire Recalled for Incorrect Raw Material Labeling
Synthes, Inc. is recalling 3.2 mm Guide Wires because the label lists an incorrect raw material. The recall covers units distributed in the USA, Canada, and Switzerland.
Product
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1022-2014·2014-02-26
Zimmer Recalls NEXGEN Knee Implant Components Due to Packaging Validation Issues
Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN…
Category
Medical Device
Distribution
Distributed nationwide
ModerateUSDA FSIS·016-2014·2014-02-26
Santa Maria Foods Recalls Various Meat Products Lacking Full USDA Inspection
Santa Maria Foods is recalling approximately 8,895 pounds of various meat products because they were imported without full USDA inspection. No illnesses have been reported.
Product
Canadian Firm Recalls Various Meat Products Without Import Inspection
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1004-2014·2014-02-26
Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1001-2014·2014-02-26
Zimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues
Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1025-2014·2014-02-26
Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues
Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.
Product
HGP II ACETABULAR CUP BON
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1017-2014·2014-02-26
Zimmer Recalls Hip Prostheses Due to Packaging Validation Issues
Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1063-2014·2014-02-26
Implantech Recalls Gelzone Shoulder Sleeves Due to Velcro Closure Defect
Implantech Associates Inc is voluntarily recalling Gelzone Shoulder Sleeves because the Velcro closure may not meet robustness requirements.
Product
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1038-2014·2014-02-26
Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations
Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.
Product
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Category
Medical Device
Distribution
Distributed nationwide